A Phase 3, Randomized, Active-controlled, Open-label, Multi-Center 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: Maintenance treatment of anemia in hemodialysis patients; MedDRA version: 9.1Level: LLTClassification code 10002272Term: Anemia

• Registration Number: EUCTR2007-004153-28-BG
• Lead Sponsor: Affymax Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-12
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

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

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 practise a highly effective method of birth control for at least 4 weeks prior to randomization, and must be willing to continue birth control until at least 4 weeks after the last dose study treatment.
4. Patients with chronic renal failure on hemodialysis for >= 3 months prior to randomization.
5. On IV or SC Epoetin maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization. In addition, Epoetin doses must be stable during the last 4 weeks prior to randomization, with stability defined as =<50% change from the maximum prescribed weekly dose (i.e., [max-min]/max =< 0.5) and with no change in prescribed frequency during the last 4 weeks prior to randomization.
6. Four consecutive Hgb values with a mean >= 10.0 and =< 12.0 g/dL during the Screening Period, and with a difference between the mean of the first two consecutive Hgb values and the mean of the last two consecutive Hgb values being =< 1.0 g/dL.
Qualifying Hgb values must be taken within the following parameters:
- Two or more days between Hgb values
- Maximum of two Hgb values within one calendar week
- 9 or more days between the first and last of the four qualifying Hgb values
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 ferrin level >= 100ng/mL within 4 weeks prior to randomization.
9. One serum or red cell folate level >= lower limit of normal within 4 weeks prior to randomization.
10. One vitamin B12 level >= lower limit of normal 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

1. Females who are pregnant or breast-feeding.
2. Known intolerance to any ESA or PEGylated molecule or to all parenteral iron supplementation products.
3. Known bleeding or coagulation disorder.
4. Known hematologic disease or cause for 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.
9. A scheduled kidney transplant (Note: patients currently on a transplant wait list are not excluded unless there is an identified donor).
10. A scheduled elective surgery that may be expected to lead to significant blood loss.
11. RBC or whole blood transfusion within 12 weeks prior to randomization.
12. Previous exposure to any investigational agent within 4 weeks prior to randomization, or planned receipt of an investigational agent, other than as specified by this protocol, during the study period.
13. Previous exposure to AF37702 Injection.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the safety and efficacy of AF37702 Injection in the maintenance treatment of anemia in hemodialysis patient.<br>To demonstrate the non-inferiority of AF37702 Injection to Epoetin in the maintenance treatment of anemia.;Secondary Objective: ;Primary end point(s): Mean change in Hgb between baseline (the mean of the five most recent Hgb values prior to randomization) and the Evaluation Period (mean Hgb from Weeks 29 through 36)