A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study of the Safety and Efficacy of AF37702 Injection for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated with Epoetin - EMERALD 2

• Conditions: Anemia in Hemodialysis Patients; MedDRA version: 9.1Level: LLTClassification code 10002034Term: Anaemia

• Registration Number: EUCTR2007-004153-28-IT
• Lead Sponsor: AFFYMAX INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-12
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Inclusion Criteria 1. Patient is informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines. 2. Males or females ≥ 18 years of age. 3. Females of child-bearing potential who are sexually active must be willing to practice a highly effective method of birth control for at least four weeks prior to randomization and must be willing to continue birth control until at least four weeks after the last dose of study treatment. 4. Patients with chronic renal failure on hemodialysis for ≥ 3 months prior to randomization. 5. On stable IV or SC Epoetin maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization. Stability is defined as ≤ 30% change from the maximum prescribed weekly dose (i.e., [max-min]/max ≤ 0.3) with no change in prescribed frequency. 6. Four consecutive Hgb values with a mean ≥ 10.0 and ≤ 12.0 g/dL during the Screening Period, with ≤1.3 g/dL difference between any of the four values taken no less than 3 days apart (Note: a maximum of six Hgb values may be obtained during a screening effort). 7. One transferrin saturation (TSAT) ≥ 20% within 4 weeks prior to randomization. 8. One ferritin level ≥ 100 ng/mL within 4 weeks prior to randomization.
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

Exclusion Criteria 1. Females who are pregnant or breast-feeding. 2. Known intolerance to any ESA, parenteral iron supplementation, or PEGylated molecules. 3. Known bleeding or coagulation disorder. 4. Known hematologic disease or cause of anemia other than renal disease (e.g., pure red cell aplasia [PRCA], homozygous sickle-cell disease, thalassemia, multiple myeloma, hemolytic anemia and myelodysplastic syndrome). 5. Poorly controlled hypertension within 4 weeks prior to randomization, per Investigator?s clinical judgment. 6. Any clinically significant medical disease or condition that, in the Investigator?s opinion, may interfere with protocol adherence or a patient?s ability to give informed consent. 7. Evidence of active malignancy within one year prior to randomization. (Note for the purposes of this protocol, active malignancy does not include: non-melanoma skin cancer, carcinoma in situ that has been completely excised, other cancers for which treatment was completed at least one year ago with no continuing treatment and no evidence of metastasis, and other cancers that were diagnosed and treatment completed more than one year ago and within the past year are without evidence of metastasis and treated only with adjuvant hormonal therapy). 8. Temporary (untunneled) dialysis access catheter.

Study & Design

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