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Phase 2a Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients

NCT03325621 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-10-21

No results posted yet for this study

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.

Conditions

  • Anemia of Chronic Kidney Disease

Interventions

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

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Pieris Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Lutz Renders, Prof. MD · Technical University, Munich

  • Ondřej Viklický, Prof.MD · Institute of Clinical and Experimental Medicine Nephrology Clinic Prague

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2019-03-30
Completion
2019-06-30

Countries

  • Czechia
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03325621 on ClinicalTrials.gov