Anemia of Chronic Kidney DiseasePhase 1/2NCT02754167
Phase Ib Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients
A Phase 1/2 study testing PRS-080#022-DP in people with Anemia of Chronic Kidney Disease, run by Pieris Pharmaceuticals GmbH at 2 sites in Germany.
Trial summary
Anticalins® are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for the treatment of anemia of chronic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- PRS-080#022-DP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesGermany
- Study dates
- 6 Jun 2016to 31 Dec 2017
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage 5 chronic kidney disease having been on hemodialysis for at least 90 days
- Patients being on stable erythropoiesis-stimulating agent (ESA) dose
- Hemoglobin (Hb) 9 - 11 g/dL
- Ferritin ≥ 300 ng/mL.
- Transferrin saturation (TSAT) ≤ 30%
- Hepcidin 5 - 50 nmol/L
Who cannot join
- Anemia due to causes other than chronic kidney disease, including hemoglobinopathies, hemolytic anemias, myelodysplasia or malignancy
- Blood transfusion within 2 months before administration of study medication.
- Iron treatment from 1 week before study medication administration until 1 week after study medication administration.
- Previous enrollment in this study
- Current or previous (within 60 days before study medication administration) treatment with another investigational drug and/or medical device or participation in another clinical study.
- Pregnancy or breast-feeding women of child bearing age.
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- Known allergy to any component of the PRS-080#022-DP formulation
- Positive for hepatitis B surface antigen, anti-hepatitis C virus antibody, or human immunodeficiency virus
- Planned surgery during the study period
- Unwilling or unable to comply with the protocol, in the judgment of the investigator
- Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, apoplexy or coronary artery bypass grafting <3 months prior screening.
- Congestive heart failure: New York Heart Association Class III or IV.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
St. Joseph Krankenhaus
Berlin
Technical University, Medical Department
Munich
About this study
Official title: Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Hepcidin Antagonist PRS-080#022-DP in Anemic Chronic Kidney Disease Patients Undergoing Hemodialysis
Anticalins® are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for the treatment of anemia of chronic disease. This Phase Ib study shall investigate the safety, pharmacokinetics and pharmacodynamics of a single administration of PRS-080#022-DP in anemic stage 5 chronic kidney disease patients undergoing hemodialysis.
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, single ascending dose phase Ib study in anemic stage 5 chronic kidney disease patients requiring hemodialysis. Eligible subjects will undergo screening assessments and PRS-080#22-DP will be administered by intravenous infusion. The study will consist of 3 dose cohorts of 2 mg/kg, 4 mg/kg, and 8 mg/kg body weight with 8 subjects in each cohort. Using a standard 6+2 design, 6 subjects in each cohort will be randomized to PRS-080#022-DP and 2 subjects in each cohort will be randomized to placebo. The decision to escalate the dose will be based on an interim analysis of clinical safety and safety laboratory data. Safety and tolerability, pharmacokinetics, pharmacodynamics as well as potential immunogenicity will be investigated.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- PRS-080#022-DP, PRS-080-Placebo#001
- Keywords
- Hepcidin, hemoglobin, iron, anemia of chronic disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRS-080#022-DPBiological
Also called PRS-080
Hepcidin antagonism to mobilize iron and to treat anemia
PRS-080-Placebo#001Biological
Also called Placebo
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| PRS-080#022-DP | Experimental | Hepcidin antagonist, single administration, ascending doses Receives: Biological: PRS-080#022-DP |
| PRS-080-Placebo#001 | Placebo comparator | Comparator treatment, single administration Receives: Biological: PRS-080-Placebo#001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Composite measure including signs and symptoms, changes from baseline heart rate and blood pressure, ECG, body temperature, respiratory rate clinical chemistry and hematology
Measured: 28 days
Secondary outcomes (6)
Pharmacokinetics of PRS-080#022
Area under the plasma concentration versus time curve (AUC) of PRS-080 in plasma
Measured: 28 days
Effects of PRS-080#022 on serum iron
Changes in total serum iron concentration compared to baseline
Measured: 28 days
Effects of PRS-080#022 on ferritin
Changes in serum ferritin concentration compared to baseline
Measured: 28 days
Effects of PRS-080#022 on transferrin saturation
Changes in serum transferrin saturation compared to baseline
Measured: 28 days
Effect of PRS-080#022 on hepcidin concentrations in plasma
Changes in hepcidin concentration compared to baseline
Measured: 28 days
Number of patients developing anti-drug antibodies
Number of patients with antibodies against PRS-080#022 at day 28 compared to baseline.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start6 Jun 2016
- Primary completion6 Feb 2017
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pieris Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Lutz Renders, Prof. MD, Principal investigator, Technical University, Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754167
- Sponsor's protocol ID
- PCS_02_15
- Status last verified
- Oct 2017
- First submitted
- 14 Apr 2016
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Hepcidin Antagonist PRS-080#022-DP in Anemic Chronic Kidney Disease Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT02754167
- Acronym / sponsor ID
- PCS_02_15
- Conditions
- Anemia of Chronic Kidney Disease
- Keywords
- Hepcidin, hemoglobin, iron, anemia of chronic disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pieris Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- 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.
Anticalins® are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for the treatment of anemia of chronic disease. This Phase Ib study shall investigate the safety, pharmacokinetics and pharmacodynamics of a single administration of PRS-080#022-DP in anemic stage 5 chronic kidney disease patients undergoing hemodialysis.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, single ascending dose phase Ib study in anemic stage 5 chronic kidney disease patients requiring hemodialysis. Eligible subjects will undergo screening assessments and PRS-080#22-DP will be administered by intravenous infusion. The study will consist of 3 dose cohorts of 2 mg/kg, 4 mg/kg, and 8 mg/kg body weight with 8 subjects in each cohort. Using a standard 6+2 design, 6 subjects in each cohort will be randomized to PRS-080#022-DP and 2 subjects in each cohort will be randomized to placebo. The decision to escalate the dose will be based on an interim analysis of clinical safety and safety laboratory data. Safety and tolerability, pharmacokinetics, pharmacodynamics as well as potential immunogenicity will be investigated.
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 |
|---|---|---|
| PRS-080#022-DP | Experimental | Biological: PRS-080#022-DPHepcidin antagonist, single administration, ascending doses |
| PRS-080-Placebo#001 | Placebo comparator | Biological: PRS-080-Placebo#001Comparator treatment, single administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with stage 5 chronic kidney disease having been on hemodialysis for at least 90 days
- Patients being on stable erythropoiesis-stimulating agent (ESA) dose
- Hemoglobin (Hb) 9 - 11 g/dL
- Ferritin ≥ 300 ng/mL.
- Transferrin saturation (TSAT) ≤ 30%
Key exclusion criteria (12 listed)
- Anemia due to causes other than chronic kidney disease, including hemoglobinopathies, hemolytic anemias, myelodysplasia or malignancy
- Blood transfusion within 2 months before administration of study medication.
- Iron treatment from 1 week before study medication administration until 1 week after study medication administration.
- Previous enrollment in this study
- Current or previous (within 60 days before study medication administration) treatment with another investigational drug and/or medical device or participation in another clinical 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 |
|---|---|---|
| PRS-080#022-DPAlso: PRS-080Hepcidin antagonism to mobilize iron and to treat anemia | Biological | PRS-080#022-DP |
| PRS-080-Placebo#001Also: PlaceboPlacebo comparator | Biological | PRS-080-Placebo#001 |
Primary outcome
Number of patients with adverse events
Time frame: 28 days
Composite measure including signs and symptoms, changes from baseline heart rate and blood pressure, ECG, body temperature, respiratory rate clinical chemistry and hematology
6 secondary outcomes
Pharmacokinetics of PRS-080#022
Time frame: 28 days
Effects of PRS-080#022 on serum iron
Time frame: 28 days
Effects of PRS-080#022 on ferritin
Time frame: 28 days
Effects of PRS-080#022 on transferrin saturation
Time frame: 28 days
Effect of PRS-080#022 on hepcidin concentrations in plasma
Time frame: 28 days
Number of patients developing anti-drug antibodies
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- 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.
Lutz Renders, Prof. MD principal investigator
Technical University, Munich
2 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 PRS-080#022-DP in people with Anemia of Chronic Kidney Disease, run by Pieris Pharmaceuticals GmbH at 2 sites in Germany.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
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?
Number of patients with adverse events (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2017.