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

NCT ID: NCT02754167

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-06

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Anemia of Chronic Kidney Disease

Keywords

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Hepcidin hemoglobin iron anemia of chronic disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PRS-080#022-DP

Hepcidin antagonist, single administration, ascending doses

Group Type EXPERIMENTAL

PRS-080#022-DP

Intervention Type BIOLOGICAL

Hepcidin antagonism to mobilize iron and to treat anemia

PRS-080-Placebo#001

Comparator treatment, single administration

Group Type PLACEBO_COMPARATOR

PRS-080-Placebo#001

Intervention Type BIOLOGICAL

Placebo comparator

Interventions

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PRS-080#022-DP

Hepcidin antagonism to mobilize iron and to treat anemia

Intervention Type BIOLOGICAL

PRS-080-Placebo#001

Placebo comparator

Intervention Type BIOLOGICAL

Other Intervention Names

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PRS-080 Placebo

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FGK Clinical Research GmbH

INDUSTRY

Sponsor Role collaborator

Pieris Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lutz Renders, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Technical University, Munich

Locations

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St. Joseph Krankenhaus

Berlin, , Germany

Site Status

Technical University, Medical Department

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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PCS_02_15

Identifier Type: -

Identifier Source: org_study_id