NCT02754167

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 6, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

April 14, 2016

Last Update Submit

October 19, 2017

Conditions

Anemia of Chronic Kidney Disease

Keywords

Hepcidinhemoglobinironanemia of chronic disease

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • Pharmacokinetics of PRS-080#022

    28 days

  • Effects of PRS-080#022 on serum iron

    28 days

  • Effects of PRS-080#022 on ferritin

    28 days

  • Effects of PRS-080#022 on transferrin saturation

    28 days

  • Effect of PRS-080#022 on hepcidin concentrations in plasma

    28 days

  • +1 more secondary outcomes

Study Arms (2)

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

PRS-080#022-DPBIOLOGICAL

Hepcidin antagonism to mobilize iron and to treat anemia

Also known as: PRS-080
PRS-080#022-DP
PRS-080-Placebo#001BIOLOGICAL

Placebo comparator

Also known as: Placebo
PRS-080-Placebo#001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Joseph Krankenhaus

Berlin, Germany

Location

Technical University, Medical Department

Munich, Germany

Location

Study Officials

  • Lutz Renders, Prof. MD

    Technical University, Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 28, 2016

Study Start

June 6, 2016

Primary Completion

February 6, 2017

Study Completion

December 31, 2017

Last Updated

October 20, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)