A Phase 2 Study of the Safety and Efficacy of AF37702 Injection for the MaintenanceTreatment of Anemia in Subjects with Chronic Renal Failure Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10058116Term: Nephrogenic anaemia; Anaemia

• Registration Number: EUCTR2008-003459-64-GB
• Lead Sponsor: Takeda Global Research & Development Centre (Europe) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Subject eligibility is determined according to the following criteria:
1. 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 authorised representative (if appropriate) 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 use adequate contraception (as defined in the informed consent form) from screening throughout the duration of the study.
5. The subject has chronic renal failure and meets one of the following criteria:
a) Has been on hemodialysis for =6 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 =10.0 and =12.0 g/dL during the Screening Period, with the difference between the mean of the first 2 consecutive Hgb values and the mean of the last 2 consecutive values being =1.0 g/dL. Qualifying Hgb values must be taken 2 or more days between Hgb values, with maximum of 2 Hgb values within one calendar week and 9 or more days between the first and last of the 4 qualifying Hgb values. (Note: a maximum of 6 Hgb values may be obtained during a screening effort).
8. The subject has 1 ferritin level =100 ng/mL within 4 weeks prior to enrollment.
9. The subject has 1 serum folate level = lower limit of normal within 4 weeks prior to enrollment.
10. The subject has 1 vitamin B12 level = lower limit of normal within 4 weeks prior to enrollment.
11. 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

Exclusion Criteria

Any subject who meets any of the following criteria will not qualify for entry into the study:
1. 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 of intensive iron replacement (ie, has received more than 500mg IV in the 28 days prior to enrollment).
7. The subject has poorly controlled hypertension within 4 weeks prior to enrollment, per investigator’s clinical judgment.
8. The subject has advanced chronic congestive heart failure – New York Heart Association Class III or IV.
9. The subject has uncontrolled, or symptomatic inflammatory disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc.)
10. The subject has a known history of seizure disorder or received anti-epileptic medication for seizure disorder within 6 months prior to enrollment.
11. The subject has any clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent.
12. The subject has evidence of active malignancy within past 5 years (except non-melanoma skin cancer or carcinoma-in-situ that has been completely excised).
13. The subject has a scheduled kidney transplant (Note: subjects currently on a transplant wait list are not excluded unless there is an identified donor).
14. The subject is anticipated to initiate dialysis during the course of the study (only applies to subjects who are not yet on dialysis).
15. The subject has a temporary (untunneled) dialysis access catheter (only applies to subjects receiving dialysis).
16. The subject has a scheduled surgery that may be expected to lead to significant blood loss.
17. The subject has previous exposure to any investigational agent within 4 weeks prior to enrollment, or planned receipt of an investigational agent, other than as specified by this protocol, during the study period.
18. The subject has previous exposure to AF37702 Injection.
19. The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to enrollment.
20. The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, sibling) of a study site employee, involved in conduct of this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified