Status:
COMPLETED
Phase 2a Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients
Lead Sponsor:
Pieris Pharmaceuticals GmbH
Collaborating Sponsors:
FGK Clinical Research GmbH
Conditions:
Anemia of Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 int...
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled, multiple ascending dose, pilot Phase 2a study in anemic stage 5 chronic kidney disease patients requiring hemodialysis. Eligible p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Any medical condition that in the judgment of the investigator might interfere with study participation or jeopardize patient's safety during the study (e.g., active infection).
Key Trial Info
Start Date :
September 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03325621
Start Date
September 30 2017
End Date
June 30 2019
Last Update
October 21 2019
Active Locations (6)
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1
University Hospital Brno
Brno, Czechia, 625 00
2
HDS - Klaudian's Hospital
Mladá Boleslav, Czechia, 293 50
3
Institute of Clinical and Experimental Medicine (ICEM)
Prague, Czechia, 140 21
4
VFN Strahov
Prague, Czechia, 169 00