A Phase 2 Study of the Safety and Efficacy of AF37702 Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Subjects Previously Treated With Epoetin - AFX01-201
- Conditions
- ANAEMIAMedDRA version: 9.1Level: LLTClassification code 10002045Term: Anaemia haemolytic
- Registration Number
- EUCTR2008-003458-13-IT
- Lead Sponsor
- TAKEDA EUROPE RESEARCH & DEVELOPMENT CENTRE LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Main Criteria for Inc\usion: Subject eligibility is determined according to the following criteri a: l. The subject is male or female and aged 18 to 90 years, inclusi ve. 2. The subject is capable ofunderstanding and complying with protocol requirements. 3. Tbe subject or the subject`s legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures. 4. A female subject of childbearing potential who is sexually active agrees to routinely use acceptable contraception from Screening throughout the duration of the study, 5. The subject has chronic renal failure and has been on peritoneal dialysis for 23 months prior to enrollment. 6. The subject is on stable SC epoetin (alfa or beta) maintenance therapy continuously prescribed for a minimum of 8 weeks prior to enrollment. Stability is defined as :5:50% change from the maximum prescribed weekly dose (ie, [max-min]/max :5:0.5) with no change in prescribed frequency during the 4 weeks prior to enrollment. 7. The subject has 4 consecutive Hgb values with a mean 210.0 and :5:12.0 g/dL during the Screening Period, with the difference between the mean of the first 2 consecuti ve Hgb values and the mean of the last 2 consecutive Hgb values being :5:1.0g/dL. Qualifying Hgb values must be taken 2 or more days between Hgb values with a maximum of2 Hgb with one calendar week and 9 or more days between the first and the last ofthe 4 qualifying Hgb values. (Note: a maximum of 6 Hbg values may be obtained during a screening effort). 8. The subject has l ferritin level z l Ou` ng/mL within 4 weeks prior to enrollment. 9. The subject has 1 serum or red cell folate level z lower limit ofnormal within 4 weeks prior to enrollment. lO. The subject has l vitamin B 12 leve! ;;::lower limit of nonnal within 4 weeks prior to enrollment. Il. The subject has a negative test result for hepatitis B surface antigen, and hepatitis C virus antibody at Screening and no known history of human immunodeficiency virus infection.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Main Criteria for Exclusion: Any subject who meets any ofthe following criteria will not qualify for entry into the study: 1. If female, the subject is pregnant or lactating or intending 10 become pregnant before, during, or within l month after end of dosing this study; or intending to donate ova during such rime periodo 2. The subject has known intolerance to any erythropoiesis-stimulating agent, ali parenteral iron supplementation products, or any PEGylated molecules. 3. The subject has known bleeding or coagulation disorder. 4. The subject has known hematologic disease or cause of anemia other than renal disease (eg, pure red cel1 aplasia [PRCA], homozygous sickle-cell disease, thalassemia, multiple myeloma, hemolytic anemia and myelodysplastic syndrome). 5. The subject has had red blood cell (RBC) or whole blood transfusion within 12 weeks prior to enrollment. 6. The subject has recei ved a recent course of intensi ve iron replacement (ie, has recei ved more than 500 mg IV
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method