Chronic Kidney DiseasesPhase 1COR-001-SC1NCT03126318
A Study of Patients With Chronic Kidney Disease to Assess the Safety of a Single Dose of COR-001
A Phase 1 study testing COR-001 in people with Chronic Kidney Diseases, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo administered subcutaneously to patients with moderate-to-severe chronic kidney disease and persistent inflammation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- COR-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2017to 19 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD stage III or IV
- Serum CRP > 2 mg/L measured twice during the Screening period at least one week apart
- Urine protein excretion < 3.5 g/24h estimated by a spot urine protein/creatinine ratio
- The patient agrees to comply with the contraception and reproduction restrictions of the study - use 2 forms of acceptable contraception
Who cannot join
- Patients with advanced CKD requiring chronic dialysis
- Hospitalization over the period of 6 weeks prior to randomization
- Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs anytime during the study Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary.
- History of or expected to undergo living related kidney transplant during the study period
- Currently receiving or planning to receive live or inactivated vaccines
- Clinical evidence or suspicion of active or smoldering infection (e.g., diabetic foot ulcer) or use of antibiotics during the Screening period
Show all 23Show fewer
- History of a positive PPD or prior diagnosis of tuberculosis
- Evidence of HIV infection or carrier state by serology at Screening
- Hepatitis B or C by serology (i.e. Hepatitis B Surface Antigen or Hepatitis C antibody positive) at Screening
- AST or ALT > 2.5x ULN at Screening
- History of liver cirrhosis or home oxygen use
- History of gastrointestinal ulceration or active diverticulitis in the 1 year prior to Screening
- Absolute neutrophil count < 2 x 109/L at Screening
- Platelet count < 100 x 109/L at Screening
- Participated in an investigational drug study within 30 days of Screening or Screening is within 5 half-lives of the investigational compound.
- Known allergy to the study drug or any of its ingredients
- Breastfeeding or a positive pregnancy test at Screening or Day -1.
- Any condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would in the opinion of the Investigator increase the risk of the subject's participation in the study.
- This would include but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy, anemia attributable to a primary hematologic disease (e.g., sickle cell anemia), or any unexplained blackouts.
- Actively treated malignancy (other than non-melanoma skin cancers) during the 1 year prior to Screening. Patients receiving hormonal treatment only during this period only may be enrolled with the approval of the medical monitor.
- Myocardial infarction during the 3 months prior to Screening or during Screening
- Severe arthritis, lupus, inflammatory bowel disease, asthma or other disease(s) or medical condition(s) that, in the opinion of the investigator, could interfere with hs-CRP or immune function
- Use of CYP substrates with a narrow therapeutic index (please see detailed table below).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Coloardo Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Cohort Dose-Escalation Study in Patients With Chronic Kidney Disease to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of COR-001 (COR-001-SC1)
This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo administered subcutaneously to patients with moderate-to-severe chronic kidney disease and persistent inflammation.
Read the detailed description
This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo administered subcutaneously to patients with moderate-to-severe chronic kidney disease (CKD) and persistent inflammation (defined as a persistently elevated serum CRP (C-Reactive Protein) level). The primary objective is to evaluate the safety of a single dose of the study drug delivered subcutaneously. Four CKD patients will be randomized to the study drug or placebo within each dosing cohort in a ratio of 3:1. The dosing cohorts are 5 mg, 15 mg, 50 mg, and 100 mg. Each patient will be given 1 dose of the study drug and then be followed for 12 weeks for primary safety, pharmacokinetic and pharmacodynamic assessments. Next, patients will continue to be followed for an additional 20 weeks (32 weeks observation in total) for safety and anti-drug antibody assessments.
Prior to dose escalation (i.e., higher total dose than studied in the preceding cohorts), there will be a formal safety review and the data will have been determined to be acceptable by a Data Safety Monitoring Board (DSMB) which will include at least one nephrologist. The safety review required for dose escalation will include at least 21 days of treatment data from the preceding cohort(s). The DSMB will also meet to review data concerning an SAE (Serious Adverse Event) that is suspected to be study drug related
The investigative team (other than an un-blinded research pharmacist or equivalent) will be blinded to the treatment assignment.
- Conditions
- Chronic Kidney Diseases
- Being tested
- COR-001, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COR-001Drug
Anti-inflammatory therapy
PlaceboDrug
Sterile water with a final buffer of 25 mM Histidine, 8.5% (w/v) trehalose and 0.05% PS80
| Study group | Role | What they receive |
|---|---|---|
| COR-001 | Active comparator | COR-001 5, 15, 50, or 100 mg dose (depending on dose cohort assigned to patient) given by subcutaneous injection one time only Receives: Drug: COR-001 |
| Placebo | Placebo comparator | Placebo at pH 6.0will be given in a volume to match the volume of COR-001 being given for the dose cohort by subcutaneous injection one time only Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of a 5 mg dose of COR-001 as measured by the incidence of adverse events
To evaluate the safety of a 5 mg dose of COR-001 delivered subcutaneously
Measured: 1 month after the 4th patient has received study drug
The safety of a 15 mg dose of COR-001 as measured by the incidence of adverse events
To evaluate the safety of a 15 mg dose of COR-001 delivered subcutaneously
Measured: 1 month after the 4th patient has received study drug
The safety of a 50 mg dose of COR-001 as measured by the incidence of adverse events
To evaluate the safety of a 50 mg dose of COR-001 delivered subcutaneously
Measured: 1 month after the 4th patient has received study drug
The safety of a 100 mg dose of COR-001 as measured by the incidence of adverse events
To evaluate the safety of a 100 mg dose of COR-001 delivered subcutaneously
Measured: 1 month after the 4th patient has received study drug
Secondary outcomes (4)
Pharmacokinetic analysis: maximum serum drug concentrations (Cmax)
To evaluate single-dose pharmacokinetics of COR-001 delivered subcutaneously
Measured: Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.
Pharmacokinetic analysis: area under the serum drug concentration-time curve (AUC)
To evaluate the single-dose pharmacokinetics of COR-001 delivered subcutaneously
Measured: Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.
Pharmacokinetic analysis: terminal elimination half-life (t1/2)
To evaluate the single-dose pharmacokinetics of COR-001 delivered subcutaneously
Measured: Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.
The effectiveness of COR-001 as measured by levels of an inflammatory marker
To evaluate the effectiveness of COR-001 as measured by CRP levels.
Measured: Screening and at weeks 1 - 5, 8, 12, 20, and 32.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start19 May 2017
- Primary completion14 Mar 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled - 4 cohorts of 4 patients each with a dosing regimen of 3:1 (active:placebo)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Corvidia Therapeutics
- Responsible party
- Sponsor
- Investigators
- Michel Chonchol, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126318
- Sponsor's protocol ID
- 16-2272
- Acronym
- COR-001-SC1
- Status last verified
- Sep 2020
- First submitted
- 5 Apr 2017
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nowak KL, Kakkar R, Devalaraja M, Lo L, Park W, Gobburu J, Kling D, Davidson M, Chonchol M. A Phase 1 Randomized Dose-Escalation Study of a Human Monoclonal Antibody to IL-6 in CKD. Kidney360. 2020 Dec 4;2(2):224-235. doi: 10.34067/KID.0005862020. eCollection 2021 Feb 25.
PubMed 35373026
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Cohort Dose-Escalation Study in Patients With Chronic Kidney Disease to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of COR-001 (COR-001-SC1)
- ClinicalTrials.gov ID
- NCT03126318
- Acronym / sponsor ID
- COR-001-SC1 / 16-2272
- Conditions
- Chronic Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Corvidia Therapeutics
- Study start
- 19 May 2017 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
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 a single dose of the study drug or placebo administered subcutaneously to patients with moderate-to-severe chronic kidney disease and persistent inflammation.
Detailed description
This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo administered subcutaneously to patients with moderate-to-severe chronic kidney disease (CKD) and persistent inflammation (defined as a persistently elevated serum CRP (C-Reactive Protein) level). The primary objective is to evaluate the safety of a single dose of the study drug delivered subcutaneously. Four CKD patients will be randomized to the study drug or placebo within each dosing cohort in a ratio of 3:1. The dosing cohorts are 5 mg, 15 mg, 50 mg, and 100 mg. Each patient will be given 1 dose of the study drug and then be followed for 12 weeks for primary safety, pharmacokinetic and pharmacodynamic assessments. Next, patients will continue to be followed for an additional 20 weeks (32 weeks observation in total) for safety and anti-drug antibody assessments.
Prior to dose escalation (i.e., higher total dose than studied in the preceding cohorts), there will be a formal safety review and the data will have been determined to be acceptable by a Data Safety Monitoring Board (DSMB) which will include at least one nephrologist. The safety review required for dose escalation will include at least 21 days of treatment data from the preceding cohort(s). The DSMB will also meet to review data concerning an SAE (Serious Adverse Event) that is suspected to be study drug related
The investigative team (other than an un-blinded research pharmacist or equivalent) will be blinded to the treatment assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled - 4 cohorts of 4 patients each with a dosing regimen of 3:1 (active:placebo)
| Arm | Type | Receives |
|---|---|---|
| COR-001 | Active comparator | Drug: COR-001COR-001 5, 15, 50, or 100 mg dose (depending on dose cohort assigned to patient) given by subcutaneous injection one time only |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo at pH 6.0will be given in a volume to match the volume of COR-001 being given for the dose cohort by subcutaneous injection one time only |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CKD stage III or IV
- Serum CRP > 2 mg/L measured twice during the Screening period at least one week apart
- Urine protein excretion < 3.5 g/24h estimated by a spot urine protein/creatinine ratio
- The patient agrees to comply with the contraception and reproduction restrictions of the study - use 2 forms of acceptable contraception
Key exclusion criteria (23 listed)
- Patients with advanced CKD requiring chronic dialysis
- Hospitalization over the period of 6 weeks prior to randomization
- Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs anytime during the study Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary.
- History of or expected to undergo living related kidney transplant during the study period
- Currently receiving or planning to receive live or inactivated vaccines
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-001Anti-inflammatory therapy | Drug | COR-001 |
| PlaceboSterile water with a final buffer of 25 mM Histidine, 8.5% (w/v) trehalose and 0.05% PS80 | Drug | Placebo |
Primary outcome
The safety of a 5 mg dose of COR-001 as measured by the incidence of adverse events
Time frame: 1 month after the 4th patient has received study drug
To evaluate the safety of a 5 mg dose of COR-001 delivered subcutaneously
The safety of a 15 mg dose of COR-001 as measured by the incidence of adverse events
Time frame: 1 month after the 4th patient has received study drug
To evaluate the safety of a 15 mg dose of COR-001 delivered subcutaneously
The safety of a 50 mg dose of COR-001 as measured by the incidence of adverse events
Time frame: 1 month after the 4th patient has received study drug
To evaluate the safety of a 50 mg dose of COR-001 delivered subcutaneously
The safety of a 100 mg dose of COR-001 as measured by the incidence of adverse events
Time frame: 1 month after the 4th patient has received study drug
To evaluate the safety of a 100 mg dose of COR-001 delivered subcutaneously
4 secondary outcomes
Pharmacokinetic analysis: maximum serum drug concentrations (Cmax)
Time frame: Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.
Pharmacokinetic analysis: area under the serum drug concentration-time curve (AUC)
Time frame: Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.
Pharmacokinetic analysis: terminal elimination half-life (t1/2)
Time frame: Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.
The effectiveness of COR-001 as measured by levels of an inflammatory marker
Time frame: Screening and at weeks 1 - 5, 8, 12, 20, and 32.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 35373026Nowak KL, Kakkar R, Devalaraja M, Lo L, Park W, Gobburu J, Kling D, Davidson M, Chonchol M. A Phase 1 Randomized Dose-Escalation Study of a Human Monoclonal Antibody to IL-6 in CKD. Kidney360. 2020 Dec 4;2(2):224-235. doi: 10.34067/KID.0005862020. eCollection 2021 Feb 25.
- Individual participant dataSharing planned: No
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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.
Michel Chonchol, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COR-001 in people with Chronic Kidney Diseases, run by University of Colorado, Denver at 1 site 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 4 inclusion and 23 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The safety of a 5 mg dose of COR-001 as measured by the incidence of adverse events (time frame: 1 month after the 4th patient has received study drug). The study lists 4 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 NCT03126318, which also lists 1 linked publication.
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 9 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.