Anemia of chronic disease MedDRA version: 20.0 Level: LLT Classification code 10054310 Term: Anemia of chronic disease System Organ Class: 100000004851
Conditions
Sponsors
Pieris Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with stage 5 CKD having been on hemodialysis for at least 90 days; 2. 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 BW of 85 kg; 3. Patients being on stable erythropoiesis-stimulating agent (ESA) dose with the beginning of Screening; 4. Patients being on stable oral or intravenous iron doses with the beginning of Screening. Iron will be kept stable for a minimum of 2 weeks during the screening period before it will be discontinued one week before the first treatment; 5. 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; 6. Serum ferritin concentration =200 ng/mL; 7. TSAT =30%; 8. Plasma hepcidin concentration at least 5 nmol/L; 9. 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. 10. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Anemia due to causes other than CKD, including hemoglobinopathies, hemolytic anemias, myelodysplasia or malignancy; 2. Blood transfusion within 2 months before administration of study medication; 3. Previous enrollment in this study; 4. Patients treated with PRS-080#022-DP in a former clinical study; 5. 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; 6. Employees of the sponsor or patients who are employees or relatives of the investigator; 7. Known allergy to any component of the PRS-080#022-DP formulation; 8. Positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibody (anti-HCV Ab), or HIV; serology test results not older than 3 months are accepted; 9. Planned surgery during the study period; 10. Known or suspected active infection; 11. Active or chronic gastrointestinal bleeding, or known coagulation disorder; 12. Unwilling or unable to comply with the protocol, in the judgment of the investigator; 13. 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; 14. Congestive heart failure: New York Heart Association Class III or IV; 15. Peripheral arterial disease with necrosis, stage IV (Fontaine) or grade III (category 5 and 6, Rutherford); 16. Screening serum folate and vitamin B12 clinically significant below lower limit of normal judged by the investigator; 17. History of malignancy 18. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine the safety and tolerability of 5 repeated intravenous administrations of PRS-080#022-DP at 4 and 8 mg/kg BW in anemic stage 5 CKD patients requiring hemodialysis.; Secondary Objective: The secondary objectives of the study are: - to determine the pharmacokinetics of PRS-080#022-DP associated with 5 repeated administrations - to evaluate the effect of 5 repeated PRS-080#022-DP administrations on plasma Hb concentrations - to evaluate the effect of 5 repeated PRS-080#022-DP administrations on pharmacodynamic parameters including serum iron, ferritin, transferrin saturation (TSAT), reticulocyte hemoglobin (RetHb), and reticulocyte count (Ret) - to evaluate the effect of 5 repeated PRS-080#022-DP administrations on hepcidin plasma levels - to collect data on immunogenicity associated with 5 repeated PRS-080#022-DP administrations ; Primary end point(s): Adverse events: Pre-treatment emergent event, treatment-emergent adverse events, serious adverse events, adverse drug reactions, unexpected adverse drug reactions, SUSARs Biochemistry: sodium, potassium, calcium, phosphate, iron, aspartate-amino-transferase, alanine-amino-transferase, alkaline phosphatase, gamma-glutamyl-transferase, creatine-phosphokinase, cholesterol, blood urea, creatinine, total bilirubin, albumin, high sensitivity c-reactive protein, Vitamin B12, folate. Coagulation: prothrombin time, activated partial thromboplastin-time test. Body temperature, physical findings, electrocardiogram, and other observations related to safety Vital signs: systolic blood pressure, diastolic blood pressure and heart rate ;Timepoint(s) of evaluation of this end point: Primary endpoints will be monitored during the entire study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity: anti-drug antibodies Pharmacokinetics (from total and free PRS-080#22-DP): Cmax (measured maximum concentration), Ctrough (plasma concentration immediately before the drug infusion), tmax (time of observed maximum concentration), lambda z (terminal rate constant) after the very last administration, t½ (terminal half-life, from lambda z after the very last administration Pharmacodynamics: iron, transferrin saturation, and ferritin in blood serum; reticulocyte hemoglobin, reticulocyte count in whole blood; hepcidin concentration in blood plasma; hemoglobin concentration Hematology: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, white blood cell count, platelet blood count ;Timepoint(s) of evaluation of this end point: Secondary endpoints will be monitored during the entire study period | — |
Countries
Czech Republic, Germany
Contacts
Public ContactProject leader
Pieris Pharmaceuticals GmbH
Outcome results
None listed