Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa.

NCT00752609 | Completed Phase 2 Results

• 3 other identifiers: AFX01_2022008-003459-64U1111-1114-1500
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to determine the efficacy and safety of Peginesatide Injection for the maintenance of anemia in patients with chronic renal failure who are on hemodialysis or do not require dialysis and who were previously treated with Darbepoetin Alfa.

Conditions

Anemia

Keywords

Anemia; Drug Therapy; Hemodialysis; Kidney Failure

Outcome Measures

Primary Outcomes (1)

• Mean Change in Hemoglobin Between Baseline and the Evaluation Period

  Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24).

  Baseline and Week 19 to Week 24.

Secondary Outcomes (6)

• Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period

  Week 19 to Week 24

• Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL

  Baseline and Week 19 to Week 24.

• Percentage of Participants With Red Blood Cell Transfusions

  Up to 24 weeks.

• Mean Hemoglobin During 4-week Intervals

  Up to 24 weeks.

• Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals.

  Up to 24 weeks.

Study Arms (1)

Peginesatide

EXPERIMENTAL

Drug: Peginesatide

Interventions

Peginesatide DRUG

Peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.

Also known as: Hematide, AF37702, Omontys

Peginesatide

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient was a man or woman 18 to 90 years of age, inclusive.
• The patient had CKD and met 1 of the following criteria:
• Had been on dialysis for ≥6 months prior to enrollment, or
• Had not yet begun dialysis (hemodialysis or peritoneal dialysis) and was not anticipated to require initiation of dialysis during participation in the study.
• The patient was on stable darbepoetin alfa maintenance therapy (either SC or IV) continuously for a minimum of 8 weeks prior to enrollment.
• The patient had 4 consecutive Hb values with a mean ≥10.0 and ≤12.0 g/dL during screening period, with the difference between the mean of the first 2 consecutive Hb values and the mean of the last 2 consecutive values being ≤1.0 g/dL.

You may not qualify if:

• The patient had known bleeding or coagulation disorder.
• The patient had known hematologic disease or cause of anemia other than renal disease (i.e., pure red cell aplasia, homozygous sickle-cell disease, thalassemia, multiplemyeloma, hemolytic anemia, and myelodysplastic syndrome).
• The patient had received a recent course of intensive iron replacement (i.e., more than 500 mg IV in the 28 days prior to enrollment).
• The patient had advanced chronic CKD defined by New York Heart Association Class III or IV.
• The patient had a known history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months prior to enrollment.
• The patient had a scheduled kidney transplant. Patients currently on a transplant waiting list were not excluded, unless there was an identified donor.

Sponsors & Collaborators

• Takeda: lead
• Affymax: collaborator

Study Sites (10)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Middlebury, Connecticut, United States

Location

Unknown Facility

Lauderdale Lakes, Florida, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Dearborn, Michigan, United States

Location

Unknown Facility

Columbus, Mississippi, United States

Location

Unknown Facility

Mineola, New York, United States

Location

Unknown Facility

Arlington, Texas, United States

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency

Interventions

peginesatide; hematide

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 27, 2012
• Results First Posted: July 27, 2012

Record last verified: 2012-06

Locations

US (10)