Trials / Completed
CompletedNCT03325621
Phase 2a Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients
Phase 2a Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Repeated Administrations Over 4 Weeks of the Hepcidin Antagonist PRS-080#022-DP in Anemic Chronic Kidney Disease Patients Undergoing Hemodialysis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Pieris Pharmaceuticals GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Anticalin® proteins 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 pilot Phase 2a study shall investigate the safety, pharmacokinetics and pharmacodynamics of repeated administrations of PRS-080#022-DP in anemic stage 5 chronic kidney disease (CKD) patients undergoing hemodialysis.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, multiple ascending dose, pilot Phase 2a study in anemic stage 5 chronic kidney disease patients requiring hemodialysis. Eligible patients will undergo screening assessments and PRS-080#22-DP will be administered by intravenous infusion. The study will consist of 2 dose cohorts of 4 mg/kg and 8 mg/kg body weight with 6 patients in each cohort. Using a standard 4+2 design, 4 patients in each cohort will be randomized to PRS-080#022-DP and 2 patients in each cohort will be randomized to placebo. The decision to escalate the dose will be based on an interim analysis of clinical and laboratory safety as well on a comparison with pharmacokinetic data. Safety and tolerability, pharmacokinetics, pharmacodynamics as well as potential immunogenicity will be investigated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PRS-080#022-DP | Biological/Vaccine: PRS-080#022-DP Hepcidin antagonism to mobilize iron and to treat anemia |
| BIOLOGICAL | PRS-080-Placebo#001 | Placebo Comparator |
Timeline
- Start date
- 2017-09-30
- Primary completion
- 2019-03-30
- Completion
- 2019-06-30
- First posted
- 2017-10-30
- Last updated
- 2019-10-21
Locations
6 sites across 2 countries: Czechia, Germany
Source: ClinicalTrials.gov record NCT03325621. Inclusion in this directory is not an endorsement.