NCT03325621

Brief Summary

Anticalin® proteins 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 pilot Phase 2a study shall investigate the safety, pharmacokinetics and pharmacodynamics of repeated administrations of PRS-080#022-DP in anemic stage 5 chronic kidney disease (CKD) patients undergoing hemodialysis.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2017

Geographic Reach
2 countries

6 active sites

Status
completed

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

Study Start

First participant enrolled

September 30, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

October 21, 2019

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

October 19, 2017

Last Update Submit

October 17, 2019

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

    112 days

Secondary Outcomes (10)

  • Cmax

    112 days

  • Effects of PRS-080#022 on serum iron

    56 days

  • Effects of PRS-080#022 on ferritin

    56 days

  • Effects of PRS-080#022 on transferrin saturation

    56 days

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

    56 days

  • +5 more secondary outcomes

Study Arms (2)

PRS-080#022-DP

ACTIVE COMPARATOR

Experimental: PRS-080#022-DP Hepcidin antagonist, repeated administrations, ascending doses

Biological: PRS-080#022-DP

PRS-080-Placebo#001

PLACEBO COMPARATOR

Experimental: PRS-080-Placebo#001 Comparator treatment, repeated administrations

Biological: PRS-080-Placebo#001

Interventions

PRS-080#022-DPBIOLOGICAL

Biological/Vaccine: PRS-080#022-DP 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 CKD having been on hemodialysis for at least 90 days;
  • Male and post-menopausal (no menses for at least 12 months without an alternative medical cause) female patients with an age of ≥18 years and with a maximum body weight of 85 kg;
  • Patients being on stable erythropoiesis stimulating agent dose for 4 weeks prior to Screening;
  • Patients being on stable oral or intravenous iron doses for 4 weeks prior to Screening;
  • Mean of 3 Hb values during the screening period, each obtained at least 7 days apart must be ≤10.5 g/dL, with a difference of ≤1.0 g/dL between the lowest and highest value;
  • Serum ferritin concentration ≥300 ng/mL;
  • Transferrin saturation ≤30%;
  • Plasma hepcidin concentration at least 5 nmol/L;
  • Screening serum folate and vitamin B12 ≥lower limit of normal Hepcidin 5 - 50 nmol/L;
  • Male patients with a female partner of childbearing potential agree to use a medically acceptable method of contraception (e.g., condoms, sexual abstinence, vasectomy), not including the rhythm method for 30 days after administration of the study medication; and
  • The patient is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF). Patient agrees to comply with the protocol-mandated procedures and visits.

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;
  • Previous enrollment in this study;
  • Patients treated with PRS-080#022-DP in a previous clinical study;
  • Current or previous (within 60 days or 5 half-lives before study medication administration) treatment with another investigational drug and/or medical device or participation in another clinical study;
  • Employees of the sponsor or patients who are employees or relatives of the investigator;
  • Known allergy to any component of the PRS-080#022-DP formulation;
  • Positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibody (anti-hepatitis C virus Ab), or human immunodeficiency virus (HIV), serology test results not older than 3 months are accepted;
  • Planned surgery during the study period;
  • Known or suspected active infection;
  • Active or chronic gastrointestinal bleeding, or known coagulation disorder;
  • Unwilling or unable to comply with the protocol, in the judgment of the investigator;
  • Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, apoplexy (sudden circulatory disturbances of an organ or specific region of the body) or coronary artery bypass grafting \<3 months prior to Screening;
  • Congestive heart failure: New York Heart Association Class III or IV;
  • Peripheral arterial disease with necrosis, stage IV (Fontaine) or grade III (category 5 and 6, Rutherford); and
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital Brno

Brno, 625 00, Czechia

Location

HDS - Klaudian's Hospital

Mladá Boleslav, 293 50, Czechia

Location

Institute of Clinical and Experimental Medicine (ICEM)

Prague, 140 21, Czechia

Location

VFN Strahov

Prague, 169 00, Czechia

Location

MZV DaVita

Düsseldorf, 40210, Germany

Location

Technical University Munich

Munich, 81675, Germany

Location

Study Officials

  • Lutz Renders, Prof. MD

    Technical University, Munich

    PRINCIPAL INVESTIGATOR

  • Ondřej Viklický, Prof.MD

    Institute of Clinical and Experimental Medicine Nephrology Clinic Prague

    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
Model Details: Multicenter, double-blind, placebo-controlled, two dose groups
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2017

First Posted

October 30, 2017

Study Start

September 30, 2017

Primary Completion

March 30, 2019

Study Completion

June 30, 2019

Last Updated

October 21, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)CZ(4)