An Open-label, Multi-center, Extension Study to Evaluate the Safety and Tolerability of AF37702 Injection (Hematide™) for the Long-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney DiseaseAm 3.1 (13 November 2008) is site specific for the DeSilva UK site only. All other sites will comply with amendment 3.

Phase 1

• Conditions: ong-Term Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease; MedDRA version: 8.1Level: LLTClassification code 10002272Term: Anemia

• Registration Number: EUCTR2006-003846-41-GB
• Lead Sponsor: Affymax, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-20
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

a. Patient is informed of the investigational nature of this study and has given written, informed consent in accordance with institutional, local, and national guidelines
b. Males or females = 18 years of age.
c. Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 4 weeks prior to study drug administration, and must be willing to continue contraception until at least 4 weeks after the last dose of study drug. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some (IUDs), sexual abstinence or vasectomized partner.
d. Patient with CKD who has received at least 24 weeks of AF37702 Injection dosing (e.g., 6 doses administered Q4W or 12 doses administered Q2W) in a previous Affymax-sponsored study.
e. One Hgb value of = 10.0 g/dL in the 4 weeks prior to study drug administration.
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

a. Known intolerance to AF37702 Injection and PEGylated products
b. History of antibodies to any erythropoiesis stimulating agent (ESA) or history of pure red cell aplasia (PRCA)
c. High likelihood of early withdrawal or interruption of the study (e.g., patient suffers from any clinically significant medical disease or condition that may, in the Investigator’s opinion, interfere with safety, assessment, or follow-up of the patient)
d. Anticipated life expectancy < 18 months
e. Receipt of any commercially available ESA other than AF37702 at any time after patient enrollment in the previous Affymax-sponsored study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): - Incidence of adverse events (AEs).<br>- Incidence of serious adverse events (SAEs), including deaths<br>- Incidence of AF37702-specific antibody formation<br>- Incidence of red blood cell (RBC) or whole blood transfusions and phlebotomies· <br>- Number and proportion of patients who maintain Hgb within 10.0 to 12.0 g/dL·<br>- Hgb level and changes in Hgb<br>- AF37702 injection doses<br>- Number and proportion of subjects with dose adjustments<br>- Vital signs and laboratory values (hematology, chemistry, and iron status. <br>;Main Objective: To evaluate the safety and tolerability of AF37702 treatment for the long term maintenance of hemoglobin (Hgb) in patients with Chronic Kidney Disease (CKD).;Secondary Objective: