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

Anemia of Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02754167
• Other study ID #: PCS_02_15
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: April 14, 2016
• Last updated: October 19, 2017
• Start date: June 6, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2017
• Source: Pieris Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2017
• Est. primary completion date: February 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia of Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Biological:
• PRS-080#022-DP
Hepcidin antagonism to mobilize iron and to treat anemia
• PRS-080-Placebo#001
Placebo comparator

Locations

Country	Name	City	State
Germany	St. Joseph Krankenhaus	Berlin
Germany	Technical University, Medical Department	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Pieris Pharmaceuticals GmbH	FGK Clinical Research GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days
Secondary	Pharmacokinetics of PRS-080#022	Area under the plasma concentration versus time curve (AUC) of PRS-080 in plasma	28 days
Secondary	Effects of PRS-080#022 on serum iron	Changes in total serum iron concentration compared to baseline	28 days
Secondary	Effects of PRS-080#022 on ferritin	Changes in serum ferritin concentration compared to baseline	28 days
Secondary	Effects of PRS-080#022 on transferrin saturation	Changes in serum transferrin saturation compared to baseline	28 days
Secondary	Effect of PRS-080#022 on hepcidin concentrations in plasma	Changes in hepcidin concentration compared to baseline	28 days
Secondary	Number of patients developing anti-drug antibodies	Number of patients with antibodies against PRS-080#022 at day 28 compared to baseline.	28 days

External Links

•   Pieris Pharmaceuticals