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

NCT02754167 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-10-20

No results posted yet for this study

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. 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.

Conditions

  • Anemia of Chronic Kidney Disease

Interventions

BIOLOGICAL

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-06
Primary Completion
2017-02-06
Completion
2017-12-31

Countries

  • 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 NCT02754167 on ClinicalTrials.gov