Phase Ib Study to Evaluate PRS-080 in Anemic Chronic Kidn... | NCT02754167

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

NCT02754167

Sponsor

Pieris Pharmaceuticals GmbH

Status

Unknown status

Last Update Posted

Oct 20, 2017Actual

Enrollment

24Actual

Phase

Phase 1Phase 2

Conditions

Anemia of Chronic Kidney Disease

Interventions

PRS-080#022-DP
PRS-080-Placebo#001

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2016Actual

Primary Completion Date

Feb 6, 2017Actual

Completion Date

Dec 31, 2017Estimated

First Submitted Date

Apr 14, 2016

First Submission Date that Met QC Criteria

Apr 27, 2016

First Posted Date

Apr 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2017

Last Update Posted Date

Oct 20, 2017Actual

Name	Class
FGK Clinical Research GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRS-080#022-DP	Experimental	Hepcidin antagonist, single administration, ascending doses	Biological: PRS-080#022-DP
PRS-080-Placebo#001	Placebo Comparator	Comparator treatment, single administration	Biological: PRS-080-Placebo#001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRS-080#022-DP	Biological	Hepcidin antagonism to mobilize iron and to treat anemia	PRS-080#022-DP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Pharmacokinetics of PRS-080#022	Area under the plasma concentration versus time curve (AUC) of PRS-080 in plasma	28 days
Effects of PRS-080#022 on serum iron	Changes in total serum iron concentration compared to baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph Krankenhaus		Berlin			Germany
Technical University, Medical Department