AnemiaPhase 1/2NCT02868229

Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

A Phase 1/2 study testing COR-001 in people with Anemia, run by Novo Nordisk A/S at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Anemia
What is being tested?: COR-001
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 61 participants
Where: 12 sitesUnited States
Study dates: 12 Sep 2016to 11 Dec 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age greater than or equal to 18 years at the time of signing of the ICF.
The patient agrees to comply with the contraception and reproduction restrictions of the study
Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening
At least 2 ferritin values during Screening > 300 ng/mL
At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50% (inclusive)

Who cannot join

Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs any time during the study
Clinical evidence or suspicion of active or smoldering infection by clinical or serologic criteria
Actively treated or active malignancy
Known or suspected occult or active bleeding
Received a red blood cell or whole blood transfusion within 2 months prior to Screening or anticipated to receive a blood transfusion at any time during the study

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Novo Nordisk Investigational Site
Astoria, New York, 11102
Novo Nordisk Investigational Site
Augusta, Georgia, 30909
Novo Nordisk Investigational Site
Chicago, Illinois, 60643
Novo Nordisk Investigational Site
Fresh Meadows, New York, 11365
Novo Nordisk Investigational Site
Great Neck, New York, 11021
Novo Nordisk Investigational Site
Hollywood, Florida, 33025
Novo Nordisk Investigational Site
Houston, Texas, 77099
Novo Nordisk Investigational Site
North Brunswick, New Jersey, 08902
Novo Nordisk Investigational Site
Northridge, California, 91324
Novo Nordisk Investigational Site
Providence, Rhode Island, 02915
Novo Nordisk Investigational Site
San Antonio, Texas, 78215
Novo Nordisk Investigational Site
Tampa, Florida, 33614

Other trials in United States

About this study

Official title: A Phase 1/2 Randomized, Double-blind, Placebo Controlled, Cohort Dose-escalation Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo

Conditions: Anemia
Being tested: COR-001, Placebo
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COR-001Drug
PlaceboOther

Study groups in NCT02868229
Study group	Role	What they receive
COR-001	Experimental	Not described Receives: Drug: COR-001
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Characterization of Maximum Tolerated Dose (MTD)
The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity.
DLTs are defined as follows:
1. Confirmed Grade 3 neutropenia and representing a decline of > 25% from baseline
2. Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia.
3. ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase)
4. ≥ Grade 4 hematologic toxicity
5. ≥ Grade 3 non-hematologic toxicity
Measured: Weeks 0-24
Change in High-sensitivity C-reactive Protein (hsCRP): Week 4
Change from the baseline in hsCRP values to week 4 are presented.
Measured: From baseline (mean of screening and day 1) to week 4
Change in Serum Amyloid A (SAA): Week 4
Change from the baseline in serum amyloid A (SAA) values to week 4 are presented.
Measured: From baseline (mean of screening and day 1) to week 4

Secondary outcomes (131)

Number of Adverse Events of Special Interest
Frequency of events of interest by treatment group and dose from baseline until the end of the safety follow-up period (week 24) were reported. Adverse events of special interest included severe infusion-related reactions, hypersensitivity reaction during study drug infusion, anaphylaxis and neutropenia events of grade 2 or higher (i.e., absolute neutrophil count <1500/mm^3 and decline by at least 25% from baseline).
Measured: Weeks 0-24
Number of Treatment Emergent Adverse Events (TEAEs)
An AE (adverse event) is any undesirable event or any untoward medical occurrence that occurs to a participant during the course of a study, or the protocol-defined time after study termination, whether or not that event is considered Study Drug-related. A TEAE was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of study. Number of TEAEs from baseline until the end of safety follow up (week 24) were presented.
Measured: Week 0-24
Electrocardiogram (ECG)
A summary of the overall ECG interpretation and clinical significance from baseline until the end of the safety follow up period (week 24) is presented and categorized as Normal, Abnormal clinically significant (CS), Abnormal non clinically significant (NCS) and Missing.
Measured: At baseline, week 6, week 12, week 18 and week 24
Number of Participants Who Developed Anti-drug Antibodies (ADAs)
Number of participants who developed ADAs from baseline until the end of the extended follow up period (week 35) were reported. Samples with detectable ADAs were classified as positive for ADAs. Samples without detectable ADAs were classified as negative for ADAs.
Measured: Weeks 0-35
Number of Participants With ADA Titers
Number of participants with ADA titers for ADA-positive samples from baseline to week 35 is presented.
Measured: Weeks 0-35
Number of Participants With Neutralizing ADAs
Number of participants with neutralizing ADAs from baseline to week 35 are presented.
Measured: From baseline (mean of screening and week 1) to week 35
Change in Transferrin Saturation (TSAT): Week 4
Change from baseline in TSAT to week 4 is presented.
Measured: From baseline (mean of screening and day 1) to week 4
Change in TSAT: Mean of Weeks 10-12
Change from baseline in TSAT to the mean of weeks 10-12 is presented.
Measured: From baseline (mean of screening and day 1), week 10, week 12
Change in Reticulocyte Hemoglobin (CHr): Week 4
Change from baseline in CHr to week 4 is presented.
Measured: From baseline (mean of screening and day 1) to week 4
Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks
Change from baseline in hs-CRP to the mean of 10-12 weeks is presented.
Measured: From baseline (mean of screening and day 1), week 10, week 12
Change in SAA: Mean of Weeks 10-12
Change from baseline in SAA to the mean of weeks 10-12 is presented.
Measured: From baseline (mean of screening and day 1), week 10, week 12
Change in Serum Pre-albumin: Mean of 10-12 Weeks
Change from baseline in serum pre-albumin to the mean of 10-12 weeks is presented.
Measured: From baseline (mean of screening and day 1), week 10, week 12
Change in Albumin: Week 12
Change from baseline in albumin to week 12 is presented.
Measured: From baseline (mean of screening and day 1) to week 12
Change in Erythropoietin Resistance Index (ERI): Week 4
Change from baseline in ERI to week 4 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).
Measured: From baseline (weekly mean of screening) to week 4
Change in ERI: Mean of Weeks 8-12
Change from baseline in ERI to the mean of weeks 8-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).
Measured: From baseline (weekly mean of screening), week 8, week 12
Change in ERI: Mean of Weeks 10-12
Change from baseline in ERI to the mean of weeks 10-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).
Measured: From baseline (weekly mean of screening), week 10, week 12
Change in CHr: Mean of Weeks 10-12
Change from baseline in CHr to the mean of weeks 10-12 is presented.
Measured: From baseline (mean of screening and day 1), week 10, week 12
Change in Hemoglobin: Week 4
Change from baseline in hemoglobin to week 4 is presented.
Measured: From baseline (mean of screening and day 1) to week 4
Change in Hemoglobin: Mean of Weeks 10-12
Change from baseline in hemoglobin to weeks 10-12 is presented.
Measured: From baseline (mean of screening and day 1), week 10, week 12
Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose
Change from baseline in hemoglobin to weeks 10-12, excluding hemoglobin values following a change in the total weekly ESA (erythropoiesis stimulating agent) dose is presented. A change is defined as the first time when the ESA weekly dose goes up by >25% or down by >25% relative to the previous week's dose.
Measured: From baseline (mean of screening and day 1), week 10, week 12
Change in ERI: Week 12
Change from baseline in ERI to week 12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).
Measured: From baseline (weekly mean of screening) to week 12
Change in ERI: Mean of Weeks 9-12
Change from baseline in ERI to the mean of weeks 9-12 is presented. ERI is defined as the epoetin alfa-equivalent dose (weight-based per week in U/kg) divided by the serum hemoglobin (in g/dL).
Measured: From baseline (weekly mean of screening), week 9, week 12
Change in Hemoglobin: Week 12
Change from baseline in hemoglobin to week 12 is presented.
Measured: From baseline (mean of screening and day 1) to week 12
Change in Hemoglobin: Week 24
Change from baseline in hemoglobin to week 24 is presented.
Measured: From baseline (mean of screening and day 1) to week 24
Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4
Change in hemoglobin from screening to peak hemoglobin at week 4 is presented.
Measured: From screening to week 4
Basophils: Week 12
The observed values of basophils at week 12 are presented.
Measured: At week 12
Basophil: Week 24
The observed values of basophils at week 24 are presented.
Measured: At week 24
Basophils to Leukocytes Ratio: Week 12
Basophils to leukocytes ratio at week 12 is presented.
Measured: At week 12
Basophils to Leukocytes Ratio: Week 24
Basophils to leukocytes ratio at week 24 is presented.
Measured: At week 24
Eosinophils: Week 12
The observed values of eosinophils at week 12 are presented.
Measured: At week 12
Eosinophils: Week 24
The observed values of eosinophils at week 24 are presented.
Measured: At week 24
Eosinophils to Leukocytes Ratio: Week 12
Eosinophils to leukocytes ratio at week 12 is presented.
Measured: At week 12
Eosinophils to Leukocytes Ratio: Week 24
The eosinophils to leukocytes ratio at week 24 is presented.
Measured: At week 24
Erythrocyte Mean Corpuscular Hemoglobin: Week 12
The observed values of erythrocyte mean corpuscular hemoglobin at week 12 are presented.
Measured: At week 12
Erythrocyte Mean Corpuscular Hemoglobin: Week 24
The observed values of erythrocyte mean corpuscular hemoglobin at week 24 are presented.
Measured: At week 24
Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12
The observed values of erythrocyte mean corpuscular HGB concentration at week 12 are presented.
Measured: At week 12
Erythrocyte Mean Corpuscular HGB Concentration: Week 24
The observed values of erythrocyte mean corpuscular HGB concentration at week 24 are presented.
Measured: At week 24
Erythrocyte Mean Corpuscular Volume: Week 12
The observed values of erythrocyte mean corpuscular volume at week 12 are presented.
Measured: At week 12
Erythrocyte Mean Corpuscular Volume: Week 24
The observed values of erythrocyte mean corpuscular volume at week 24 are presented.
Measured: At week 24
Erythrocytes: Week 12
The observed values of erythrocytes at week 12 are presented.
Measured: At week 12
Erythrocytes: Week 24
The observed values of erythrocytes at week 24 are presented.
Measured: At week 24
Hematocrit: Week 12
The observed values of hematocrit at week 12 are presented.
Measured: At week 12
Hematocrit: Week 24
The observed values of hematocrit at week 24 are presented.
Measured: At week 24
Hemoglobin: Week 12
The observed values of hemoglobin at week 12 are presented.
Measured: At week 12
Hemoglobin: Week 24
The observed values of hemoglobin at week 24 are presented.
Measured: At week 24
Hypochromatic Red Cells Week 12
The observed values of hypochromatic red cells at week 12 are presented.
Measured: At week 12
Hypochromatic Red Cells: Week 24
The observed values of hypochromatic red cells at week 24 are presented.
Measured: At week 24
Leukocytes: Week 12
The observed values of leukocytes at week 12 are presented.
Measured: At week 12
Leukocytes: Week 24
The observed values of leukocytes at week 24 are presented.
Measured: At week 24
Lymphocytes: Week 12
The observed values of lymphocytes at week 12 are presented.
Measured: At week 12
Lymphocytes: Week 24
The observed values of lymphocytes at week 24 are presented.
Measured: At week 24
Lymphocytes to Leukocytes Ratio: Week 12
Lymphocytes to leukocytes ratio at week 12 is presented.
Measured: At week 12
Lymphocytes to Leukocytes Ratio at Week 24
Lymphocytes to leukocytes ratio at week 24 is presented.
Measured: At week 24
Monocytes: Week 12
The observed values of monocytes at week 12 are presented.
Measured: At week 12
Monocytes: Week 24
The observed values of monocytes at week 24 are presented.
Measured: At week 24
Monocytes to Leukocytes Ratio: Week 12
Monocytes to leukocytes ratio at week 12 is presented.
Measured: At week 12
Monocytes to Leukocytes Ratio: Week 24
Monocytes to leukocytes ratio at week 24 is presented.
Measured: At week 24
Neutrophils: Week 12
The observed values of neutrophils at week 12 are presented.
Measured: At week 12
Neutrophils: Week 24
The observed values of neutrophils at week 24 are presented.
Measured: At week 24
Neutrophils to Leukocytes Ratio: Week 12
Neutrophils to leukocytes ratio at week 12 is presented.
Measured: At week 12
Neutrophils to Leukocytes Ratio: Week 24
Neutrophils to leukocytes ratio at week 24 is presented.
Measured: At week 24
Platelets: Week 12
The observed values of platelets at week 12 are presented.
Measured: At week 12
Platelets: Week 24
The observed values of platelets at week 24 are presented.
Measured: At week 24
Reticulocytes to Erythrocytes Ratio: Week 12
Reticulocytes to erythrocytes ratio at week 12 is presented.
Measured: At week 12
Reticulocytes to Erythrocytes Ratio: Week 24
Reticulocytes to erythrocytes ratio at week 24 is presented.
Measured: At week 24
Alanine Aminotransferase: Week 12
The observed values of alanine aminotransferase at week 12 are presented.
Measured: At week 12
Alanine Aminotransferase: Week 24
The observed values of alanine aminotransferase at week 24 are presented.
Measured: At week 24
Albumin: Week 12
The observed values of albumin at week 12 are presented.
Measured: At week 12
Albumin: Week 24
The observed values of albumin at week 24 are presented.
Measured: At week 24
Alkaline Phosphatase: Week 12
The observed values of alkaline phosphatase at week 12 are presented.
Measured: At week 12
Alkaline Phosphatase: Week 24
The observed values of alkaline phosphatase at week 24 are presented.
Measured: At week 24
Aspartate Aminotransferase: Week 12
The observed values of aspartate aminotransferase at week 12 are presented.
Measured: At week 12
Aspartate Aminotransferase: Week 24
The observed values of aspartate aminotransferase at week 24 are presented.
Measured: At week 24
Bicarbonate: Week 12
The observed values of bicarbonate at week 12 are presented.
Measured: At week 12
Bicarbonate: Week 24
The observed values of bicarbonate at week 24 are presented.
Measured: At week 24
Bilirubin: Week 12
The observed values of bilirubin at week 12 are presented.
Measured: At week 12
Bilirubin: Week 24
The observed values of bilirubin at week 24 are presented.
Measured: At week 24
Calcium: Week 12
The observed values of calcium at week 12 are presented.
Measured: At week 12
Calcium: Week 24
The observed values of calcium at week 24 are presented.
Measured: At week 24
Chloride: Week 12
The observed values of chloride at week 12 are presented.
Measured: At week 12
Chloride: Week 24
The observed values of chloride at week 24 are presented.
Measured: At week 24
Cholesterol: Week 12
The observed values of cholesterol at week 12 are presented.
Measured: At week 12
Cholesterol: Week 24
The observed values of cholesterol at week 24 are presented.
Measured: At week 24
Creatinine: Week 12
The observed values of creatinine at week 12 are presented.
Measured: At week 12
Creatinine: Week 24
The observed values of creatinine at week 24 are presented.
Measured: At week 24
Direct Bilirubin: Week 12
The observed values of direct bilirubin at week 12 are presented.
Measured: At week 12
Direct Bilirubin: Week 24
The observed values of direct bilirubin at week 24 are presented.
Measured: At week 24
Glucose: Week 12
The observed values of glucose at week 12 are presented.
Measured: At week 12
Glucose: Week 24
The observed values of glucose at week 24 are presented.
Measured: At week 24
High-density Lipoprotein (HDL) Cholesterol: Week 12
The observed values of HDL cholesterol at week 12 are presented.
Measured: At week 12
HDL Cholesterol: Week 24
The observed values of HDL cholesterol at week 24 are presented.
Measured: At week 24
Hepcidin-25: Week 12
The observed values of hepcidin-25 at week 12 are presented.
Measured: At week 12
Hepcidin-25: Week 24
The observed values of hepcidin-25 at week 24 are presented.
Measured: At week 24
Low-density Lipoproteins (LDL) Cholesterol: Week 12
The observed values of LDL cholesterol at week 12 are presented.
Measured: At week 12
LDL Cholesterol: Week 24
The observed values of LDL cholesterol at week 24 are presented.
Measured: At week 24
Lipoprotein-a: Week 12
The observed values of lipoprotein-a at week 12 are presented.
Measured: At week 12
Lipoprotein-a: Week 24
The observed values of lipoprotein-a at week 24 are presented.
Measured: At week 24
Phosphate: Week 12
The observed values of phosphate at week 12 are presented.
Measured: At week 12
Phosphate: Week 24
The observed values of phosphate at week 24 are presented.
Measured: At week 24
Potassium: Week 12
The observed values of potassium at week 12 are presented.
Measured: At week 12
Potassium: Week 24
The observed values of potassium at week 24 are presented.
Measured: At week 24
Sodium: Week 12
The observed values of sodium at week 12 are presented.
Measured: At week 12
Sodium: Week 24
The observed values of sodium at week 24 are presented.
Measured: At week 24
Triglycerides: Week 12
The observed values of triglyceride at week 12 are presented.
Measured: At week 12
Triglycerides: Week 24
The observed values of triglycerides at week 24 are presented.
Measured: At week 24
Urea Nitrogen: Week 12
The observed values of urea nitrogen at week 12 are presented.
Measured: At week 12
Urea Nitrogen: Week 24
The observed values of urea nitrogen at week 24 are presented.
Measured: At week 24
Pre-dialysis Body Mass Index (BMI): Week 12
Pre-dialysis BMI values at week 12 are presented.
Measured: At week 12
Pre-infusion BMI: Week 11
Pre-infusion BMI values at week 11 are presented.
Measured: At week 11
Pre-dialysis Diastolic Blood Pressure: Week 12
Pre-dialysis diastolic blood pressure values at week 12 are presented.
Measured: At week 12
Pre-dialysis Diastolic Blood Pressure: Week 24
Pre-dialysis diastolic blood pressure values at week 24 are presented.
Measured: At week 24
Pre-infusion Diastolic Blood Pressure: Week 11
Pre-infusion diastolic blood pressure values at week 11 are presented.
Measured: At week 11
Pre-dialysis Heart Rate: Week 12
Pre-dialysis heart rate values at week 12 are presented.
Measured: At week 12
Pre-dialysis Heart Rate: Week 24
Pre-dialysis heart rate values at week 24 are presented.
Measured: At week 24
Pre-infusion Heart Rate: Week 11
Pre-infusion heart rate values at week 11 are presented.
Measured: At week 11
Pre-dialysis Respiration Rate: Week 12
Pre-dialysis respiration rate values at week 12 are presented.
Measured: At week 12
Pre-dialysis Respiration Rate: Week 24
Pre-dialysis respiration rate values at week 24 are presented.
Measured: At week 24
Pre-infusion Respiration Rate: Week 11
Pre-infusion respiration rate values at week 11 are presented.
Measured: At week 11
Pre-dialysis Systolic Blood Pressure: Week 12
Pre-dialysis values of systolic blood pressure at week 12 are presented.
Measured: At week 12
Pre-dialysis Systolic Blood Pressure: Week 24
Pre-dialysis values of systolic blood pressure at week 24 are presented.
Measured: At week 24
Pre-infusion Systolic Blood Pressure: Week 11
Pre-infusion systolic blood pressure values at week 11 are presented.
Measured: At week 11
Pre-dialysis Weight: Week 12
Pre-dialysis weight values at week 12 are presented.
Measured: At week 12
Pre-infusion Weight: Week 11
Pre-infusion weight values at week 11 are presented.
Measured: At week 11
Pre-dialysis Temperature: Week 12
Pre-dialysis temperature values at week 12 are presented.
Measured: At week 12
Pre-dialysis Temperature: Week 24
Pre-dialysis temperature values at week 24 are presented.
Measured: At week 24
Pre-infusion Temperature: Week 11
Pre-infusion temperature values at week 11 are presented.
Measured: At week 11
Area Under the Serum Concentration Time Curve From Time 0 to Infinity (AUC 0-α) of COR-001
Area under the serum concentration time curve from time 0 to infinity (AUC 0-α) of COR-001 is presented.
Measured: Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Elimination Half-life in the Initial Phase (t 1/2,α)
Elimination half-life in the initial phase (t 1/2,α) is presented from week 0 to week 35.
Measured: Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Elimination Half-life in the Terminal Phase (t 1/2, z)
Elimination half-life in the terminal phase(t 1/2, z) is presented from week 0 to week 35.
Measured: Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Maximum Serum Concentration (Cmax)
Maximum serum concentration (Cmax) of COR-001 from week 0 to week 35 is presented.
Measured: Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).
Impact of ADAs on Pharmacokinetics
Presence of ADA was a covariate for pharmacokinetics (PK) affecting V1 (volume of distribution for the central compartment). Impact of ADAs on V1 from baseline to week 35 is presented. In the below table, result presented is the bootstrap parameter estimate of the effect of ADA on V1 for a PK model that includes data for all arms combined.
Measured: Week 1 (day 1, 3, and 5), Week 2 (day 8), Week 3 (day 15), Week 5 (day 29), Week 7 (day 43), Week 8 (day 50), Week 9 (day 57), Week 11 (day 71 and 75), Week 14 (day 92), Week 18 (day 120) and Week 35 (day 239).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 201611 Dec 2018

First posted16 Aug 2016 (estimated)
Study start12 Sep 2016
Primary completion11 Dec 2018
Study completion11 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AnemiaStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02868229
Sponsor's protocol ID: NN6018-4791
Status last verified: Jul 2021
First submitted: 9 Aug 2016
Last updated: 30 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

Pergola PE, Devalaraja M, Fishbane S, Chonchol M, Mathur VS, Smith MT, Lo L, Herzog K, Kakkar R, Davidson MH. Ziltivekimab for Treatment of Anemia of Inflammation in Patients on Hemodialysis: Results from a Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2021 Jan;32(1):211-222. doi: 10.1681/ASN.2020050595. Epub 2020 Dec 3.
PubMed 33272965
Pergola PE, Davidson M, Jensen C, Mohseni Zonoozi AA, Raj DS, Andreas Schytz P, Tuttle KR, Perkovic V. Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3-5: An Analysis of a Randomized Trial (RESCUE). J Am Soc Nephrol. 2024 Jan 1;35(1):74-84. doi: 10.1681/ASN.0000000000000245. Epub 2023 Dec 13.
PubMed 38088558

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Randomized, Double-blind, Placebo Controlled, Cohort Dose-escalation Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001
ClinicalTrials.gov ID: NCT02868229
Acronym / sponsor ID: NN6018-4791
Conditions: Anemia
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 12 Sep 2016 (actual)
Primary completion: 11 Dec 2018 (actual)
Study completion: 11 Dec 2018 (actual)
First posted: 16 Aug 2016 (estimated)
Results: Posted 30 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
COR-001	Experimental	Drug: COR-001
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age greater than or equal to 18 years at the time of signing of the ICF.
The patient agrees to comply with the contraception and reproduction restrictions of the study
Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening
At least 2 ferritin values during Screening > 300 ng/mL
At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50% (inclusive)

Key exclusion criteria (5 listed)

Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs any time during the study
Clinical evidence or suspicion of active or smoldering infection by clinical or serologic criteria
Actively treated or active malignancy
Known or suspected occult or active bleeding
Received a red blood cell or whole blood transfusion within 2 months prior to Screening or anticipated to receive a blood transfusion at any time during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COR-001	Drug	COR-001
Placebo	Other	Placebo

Primary outcome

Characterization of Maximum Tolerated Dose (MTD)
Time frame: Weeks 0-24
The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity. DLTs are defined as follows: 1. Confirmed Grade 3 neutropenia and representing a decline of > 25% from baseline 2. Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. 3. ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase) 4. ≥ Grade 4 hematologic toxicity 5. ≥ Grade 3 non-hematologic toxicity
Change in High-sensitivity C-reactive Protein (hsCRP): Week 4
Time frame: From baseline (mean of screening and day 1) to week 4
Change from the baseline in hsCRP values to week 4 are presented.
Change in Serum Amyloid A (SAA): Week 4
Time frame: From baseline (mean of screening and day 1) to week 4
Change from the baseline in serum amyloid A (SAA) values to week 4 are presented.

131 secondary outcomes

Number of Adverse Events of Special Interest
Time frame: Weeks 0-24
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Week 0-24
Electrocardiogram (ECG)
Time frame: At baseline, week 6, week 12, week 18 and week 24
Number of Participants Who Developed Anti-drug Antibodies (ADAs)
Time frame: Weeks 0-35
Number of Participants With ADA Titers
Time frame: Weeks 0-35
Number of Participants With Neutralizing ADAs
Time frame: From baseline (mean of screening and week 1) to week 35
Change in Transferrin Saturation (TSAT): Week 4
Time frame: From baseline (mean of screening and day 1) to week 4
Change in TSAT: Mean of Weeks 10-12
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Change in Reticulocyte Hemoglobin (CHr): Week 4
Time frame: From baseline (mean of screening and day 1) to week 4
Change in High Sensitivity C-reactive Protein (Hs-CRP): Mean of 10-12 Weeks
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Change in SAA: Mean of Weeks 10-12
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Change in Serum Pre-albumin: Mean of 10-12 Weeks
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Change in Albumin: Week 12
Time frame: From baseline (mean of screening and day 1) to week 12
Change in Erythropoietin Resistance Index (ERI): Week 4
Time frame: From baseline (weekly mean of screening) to week 4
Change in ERI: Mean of Weeks 8-12
Time frame: From baseline (weekly mean of screening), week 8, week 12
Change in ERI: Mean of Weeks 10-12
Time frame: From baseline (weekly mean of screening), week 10, week 12
Change in CHr: Mean of Weeks 10-12
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Change in Hemoglobin: Week 4
Time frame: From baseline (mean of screening and day 1) to week 4
Change in Hemoglobin: Mean of Weeks 10-12
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Change in Hemoglobin: Mean of Weeks 10-12, Excluding Hemoglobin Values Following a Change in the Total Weekly ESA Dose
Time frame: From baseline (mean of screening and day 1), week 10, week 12
Change in ERI: Week 12
Time frame: From baseline (weekly mean of screening) to week 12
Change in ERI: Mean of Weeks 9-12
Time frame: From baseline (weekly mean of screening), week 9, week 12
Change in Hemoglobin: Week 12
Time frame: From baseline (mean of screening and day 1) to week 12
Change in Hemoglobin: Week 24
Time frame: From baseline (mean of screening and day 1) to week 24
Change in Hemoglobin From Screening to Peak Hemoglobin: Week 4
Time frame: From screening to week 4
Basophils: Week 12
Time frame: At week 12
Basophil: Week 24
Time frame: At week 24
Basophils to Leukocytes Ratio: Week 12
Time frame: At week 12
Basophils to Leukocytes Ratio: Week 24
Time frame: At week 24
Eosinophils: Week 12
Time frame: At week 12
Eosinophils: Week 24
Time frame: At week 24
Eosinophils to Leukocytes Ratio: Week 12
Time frame: At week 12
Eosinophils to Leukocytes Ratio: Week 24
Time frame: At week 24
Erythrocyte Mean Corpuscular Hemoglobin: Week 12
Time frame: At week 12
Erythrocyte Mean Corpuscular Hemoglobin: Week 24
Time frame: At week 24
Erythrocyte Mean Corpuscular Hemoglobin (HGB) Concentration: Week 12
Time frame: At week 12
Erythrocyte Mean Corpuscular HGB Concentration: Week 24
Time frame: At week 24
Erythrocyte Mean Corpuscular Volume: Week 12
Time frame: At week 12
Erythrocyte Mean Corpuscular Volume: Week 24
Time frame: At week 24
Erythrocytes: Week 12
Time frame: At week 12

Results and safety

Results posted to the registry on 30 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	12	11
COR-001 2 mg	16	16
COR-001 6 mg	16	15
COR-001 20 mg	17	12

Primary outcome: Characterization of Maximum Tolerated Dose (MTD)

Time frame: Weeks 0-24. Number. Unit: Events

Measure	Placebo n = 12	COR-001 2 mg n = 16	COR-001 6 mg n = 16	COR-001 20 mg n = 17
Infection SAEs with confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia.	0	0	0	0
>= Grade 3 ALT or AST	0	0	0	0
>= Grade 4 hematologic toxicity	0	0	0	0
>= Grade 3 non-hematologic toxicity	0	0	0	0
Confirmed Grade 3 neutropenia and representing a decline of > 25% from baseline	0	0	0	0

Population analysed: The MTD analysis population included all participants in the safety analysis population, which included all participants randomized and treated with any amount of study medication with exception of those replaced due to a non-safety reason.

Primary outcome: Change in High-sensitivity C-reactive Protein (hsCRP): Week 4

Time frame: From baseline (mean of screening and day 1) to week 4. Mean (Standard Deviation). Unit: Milligrams per liter (mg/L)

Measure	Placebo n = 10	COR-001 2 mg n = 16	COR-001 6 mg n = 11	COR-001 20 mg n = 12
Value	0.373 (3.765)	-10.383 (10.395)	-11.981 (8.232)	-14.561 (11.836)

Placebo vs COR-001 2 mg: Differences of LS Means: -5.666 (95% CI -9.082 to -2.250), p = 0.002, ANCOVA
Placebo vs COR-001 6 mg: Differences of LS Means: -6.913 (95% CI -10.613 to -3.214), p <0.001, ANCOVA
Placebo vs COR-001 20 mg: Differences of LS Means: -9.591 (95% CI -13.217 to -5.965), p <0.001, ANCOVA

Population analysed: The pharmacodynamic (PD) population included all randomized participants who received their assigned study drug, had any PD assessments, and did not have major protocol violations. Overall number of participants analysed = number of participants with available data.

Primary outcome: Change in Serum Amyloid A (SAA): Week 4

Time frame: From baseline (mean of screening and day 1) to week 4. Mean (Standard Deviation). Unit: mg/L

Measure	Placebo n = 9	COR-001 2 mg n = 16	COR-001 6 mg n = 10	COR-001 20 mg n = 10
Value	-3.733 (6.955)	-22.056 (37.914)	-9.878 (6.687)	-31.910 (41.502)

131 secondary outcomes are reported in the full results.

Adverse events

Time frame: Weeks 0-24. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 12 (25%)	7 of 12 (58.3%)	0 of 12
COR-001 2 mg	4 of 16 (25%)	11 of 16 (68.8%)	0 of 16
COR-001 6 mg	7 of 16 (43.8%)	15 of 16 (93.8%)	2 of 16
COR-001 20 mg	6 of 17 (35.3%)	10 of 17 (58.8%)	2 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33272965Pergola PE, Devalaraja M, Fishbane S, Chonchol M, Mathur VS, Smith MT, Lo L, Herzog K, Kakkar R, Davidson MH. Ziltivekimab for Treatment of Anemia of Inflammation in Patients on Hemodialysis: Results from a Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2021 Jan;32(1):211-222. doi: 10.1681/ASN.2020050595. Epub 2020 Dec 3.
Derived from this study: PubMed 38088558Pergola PE, Davidson M, Jensen C, Mohseni Zonoozi AA, Raj DS, Andreas Schytz P, Tuttle KR, Perkovic V. Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3-5: An Analysis of a Randomized Trial (RESCUE). J Am Soc Nephrol. 2024 Jan 1;35(1):74-84. doi: 10.1681/ASN.0000000000000245. Epub 2023 Dec 13.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Transparency (dept. 1452) study director

Novo Nordisk A/S

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing COR-001 in people with Anemia, run by Novo Nordisk A/S at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Characterization of Maximum Tolerated Dose (MTD) (time frame: Weeks 0-24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02868229, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.