Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.

NCT00752791 | Completed Phase 2 Results

• 3 other identifiers: AFX01_2012008-003458-13U1111-1114-0301
• Study Type: interventional
• Target: 59
• Locations: 5 countries
• Sites: 23

Brief Summary

The purpose of this study is to determine the efficacy and safety of peginesatide injection for maintenance treatment of anemia in participants on peritoneal dialysis.

Conditions

Anemia

Keywords

Anemia; Drug Therapy; Peritoneal Dialysis.

Outcome Measures

Primary Outcomes (1)

• Mean Change in Hemoglobin Between Baseline and the Evaluation Period

  The primary efficacy endpoint was the 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 20 to 25).

  Baseline and Week 20 to Week 25.

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 20 to Week 25.

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

  Baseline and Week 20 to Week 25.

• Percentage of Participants With Red Blood Cell Transfusions

  Up to 25 weeks.

• Mean Hemoglobin During 4-week Intervals

  Up to 25 weeks.

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

  Up to 25 weeks.

Study Arms (1)

Peginesatide

EXPERIMENTAL

Drug: Peginesatide

Interventions

Peginesatide DRUG

Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin 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 and 18 to 90 years of age, inclusive.
• The patient had CKD and had been on peritoneal dialysis for ≥3 months before enrollment.
• The patient was on stable SC epoetin (alfa or beta) maintenance therapy continuously prescribed 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 the screening period, with the difference between the mean of the first confirmed (2 consecutive) Hb values and the mean of the last confirmed (2 consecutive) Hb values being ≤1.0 g/dL.
• The patient had 1 ferritin level ≥100 ng/mL within 4 weeks before enrollment.

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 (e.g., pure red cell aplasia, homozygous sickle-cell disease, thalassemia, multiple myeloma, 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 before enrollment).
• The patient had advanced chronic congestive heart failure 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 before enrollment.
• The patient had a scheduled kidney transplant. (Note: patients who were currently on a transplant waiting list were not excluded unless there was an identified donor).

Sponsors & Collaborators

• Takeda: lead
• Affymax: collaborator

Study Sites (23)

Unknown Facility

Azusa, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Whittier, California, United States

Location

Unknown Facility

Naples, Florida, United States

Location

Unknown Facility

Decatur, Georgia, United States

Location

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Evergreen Park, Illinois, United States

Location

Unknown Facility

Wichita, Kansas, United States

Location

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Baton Rouge, Louisiana, United States

Location

Unknown Facility

New Iberia, Louisiana, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

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Columbus, Mississippi, United States

Location

Unknown Facility

Tupelo, Mississippi, United States

Location

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New York, New York, United States

Location

Unknown Facility

Williamsville, New York, United States

Location

Unknown Facility

Canton, Ohio, United States

Location

Unknown Facility

Arlington, Texas, United States

Location

Unknown Facility

Tyler, Texas, United States

Location

Unknown Facility

Fairfax, Virginia, United States

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Unknown Facility

Mechanicsville, Virginia, United States

Location

Unknown Facility

New Lambtom, New South Wales, Australia

Location

Unknown Facility

Modena, Modena, Italy

Location

Unknown Facility

Dunedin, Dunedin, New Zealand

Location

Unknown Facility

London, England, United Kingdom

Location

MeSH Terms

Conditions

Anemia

Interventions

peginesatide; hematide

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic 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: NA
• 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: October 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 15, 2012
• Results First Posted: August 15, 2012

Record last verified: 2012-08

Locations

NZ (1); US (19); GB (1); IT (1); AU (1)