A Phase 2 Study of the Safety and Efficacy of AF37702 Injection for the Maintenance Treatment of Anemia in Subjects with Chronic Renal Failure Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa - AFX01-202
- Conditions
- ANAEMIAMedDRA version: 9.1Level: LLTClassification code 10002045Term: Anaemia haemolytic
- Registration Number
- EUCTR2008-003459-64-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
- 100
Main Criteria for lnclusion: Subject eligibility is determined according to the following criteria: l. The subject is male or female and aged 18 to 90 years, inclusive. 2. The subject is capable of understanding and complying with protocol requirements. 3. The subject or the subject`s legally authorized representative, (if appropriate), signs a written, informed consent form prior to the initiation of any study procedures. 4. A female subject of childbearing potenti al who is sexually active agrees to use adequate contraception (as defined in the informed consent form) from screening throughout the duration ofthe study. 5. The subject has chronic renal failure and meets one of the following criteria: a) Has been on hemodialysis for z6 months prior to enrollment. b) Has not yet begun dialysis (hemodialysis or peritoneal dialysis) and is not anticipated to transition to dialysis during participation in the study. 6. The subject is on stable darbepoetin alfa maintenance therapy (either SC or IV) continuously prescribed for a minimum of 8 weeks prior to enrollment. Stability is defined as :::;50%change from the maximum prescribed weekly dose (ie, [max-min]/max :::;0.5)with no change in prescribed frequency during the last 4 weeks prior to enrollment. 7. The subject has 4 consecutive Hgb values with a mean zlO.O and :0;12.0g/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 consecuti ve values being :0;1.0gldL. Qualifying Hgb values must be taken2 or more days between Hgb values, with maximum of2 Hgb values within one calcndar week and 9 or more days between the first and last ofthe 4 qualifying Hgb values. (Note: a maximum of 6 Hgb values may be obtained during a screening effort). 8. The subject has I ferritin leve! z 100 nglmL within 4 weeks prior to enrollment. 9. The subject has l serum or red cell folate level z lower limit ofnormal within 4 weeks prior to enrollment. lO. The subject has l vitamin B 12 level z lower limit of normal within 4 weeks prior to enrollment. Il. The subject has a negati ve test refult for hepatitis B surface antigen, and hepatitis C virus antibody at Screening and no knOWJ1history ofhuman 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: l. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 28 days after the end of this study; or intending to donate ova during such time period. 2. The subject has known intolerance to any ESA, all parenteral iron supplementation products, or any PEGylated molecule. 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, PRCA, homozygous sickle-cell disease, thalassemia, multiple myeloma, hemolytic anemia and myelodysplastic syndrome). 5. The subject has had RBC or whole blood transfusion within 12 weeks prior to enrollment. 6. The subject has received a recent course ofintensive iron replacement (ie, has received more than 500 mg IV in the 28 days prior to enrollment). 7. The subject has poorly controlled hypertension witlu`n4 weeks prior to enrollment, per investigator`s clinical judgment.
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