Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease

NCT00314795 | Completed Phase 2 Results

• 2 other identifiers: AFX01-062005-004944-30
• Study Type: interventional
• Target: 22
• Locations: 3 countries
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the ability of peginesatide (AF37702) to increase and maintain increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on dialysis, receiving regular hemodialysis or peritoneal dialysis, or following renal transplant) with confirmed antibody-mediated pure red cell aplasia (PRCA).

Conditions

Anemia; Chronic Kidney Disease; Chronic Renal Failure; Pure Red Cell Aplasia

Keywords

Drug Therapy; pure red cell aplasia; PRCA; chronic kidney disease; CKD; chronic renal failure; CRF; anemia; erythropoietin; EPO; erythropoiesis stimulating agent; ESA; hemoglobin; Hb; Hgb; red blood cell; red blood cell production

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Experienced Increase and Maintain Hemoglobin Levels (Two Consecutive Values) Greater Than or Equal to the Lower Limit of the Target Range in the Absence of Red Blood Cell Transfusion in the Previous 28 Days by Week 24

  Percentage of participants who experienced increase and maintain hemoglobin levels (two consecutive values) greater than or equal to the lower limit (11 g/dL) in the absence of red blood cell transfusion in the previous 28 days by week 24 were reported.

  Up to Week 24

Secondary Outcomes (4)

• Number of Red Blood Cells (RBCs) Transfusions During the 26 Weeks Pre-treatment Period (Prior to Enrollment) and During 13- and 26 Weeks Intervals During the Study

  26 weeks prior to enrollment up to end of study (up to 60 months)

• Percentage of Participants With RBC Transfusions During the 26-week Pre-treatment Period and During 13- and 26-week Intervals During the Study

  26 weeks prior to enrollment up to end of study (up to 60 months)

• Time to Initial Achievement of Hemoglobin (Hgb) Greater Than or Equal to the Lower Limit of the Target Range in the Absence of Red Blood Cell Transfusions in the Previous 28 Days

  Up to 60 months

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation

  From signing of informed consent form up to Month 60

Study Arms (1)

Peginesatide

EXPERIMENTAL

Peginesatide 0.05 mg/kg injection, subcutaneously as a starting dose followed by peginesatide 0.1 mg/kg injection, subcutaneously once every 4 weeks for up to 6 months. Individual dose of peginesatide injection was modified based on hemoglobin levels. Dose adjustments were made in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL.

Drug: Peginesatide

Interventions

Peginesatide DRUG

Peginesatide injection

Also known as: Omontys, Hematide, AF37702

Peginesatide

Eligibility Criteria

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

You may qualify if:

• Participants who have confirmed antibody-mediated Pure red cell aplasia (PRCA) are potentially eligible for enrollment into this study.
• Participants must be ≥ 18 years old at the time of consent.
• Erythropoiesis stimulating agents (ESAs) must be discontinued for a minimum of 1 month prior to screening.
• Participant requires periodic transfusions to maintain hemoglobin.
• Hemoglobin \< 10 g/dL for at least 2 measurements or participant has received a transfusion within the past 4 weeks to achieve a hemoglobin \> 10 g/dL.
• Confirmation that an anti-erythropoietin antibody sample was obtained for analysis by the central reference laboratory within 1 month prior to baseline.
• Participants can either be participants with chronic kidney disease not yet requiring renal replacement therapy (participants not on dialysis), those on regular hemodialysis or peritoneal dialysis, or following a renal transplant.
• Participants may or may not have previously been treated with immunosuppressive therapy.
• Pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening.
• Written informed consent must be obtained.

You may not qualify if:

• Participants already successfully on another erythropoietic agent.
• Abnormal bone marrow findings consistent with the diagnosis of myelodysplasia, a myeloproliferative disorder, hematologic malignancy or evidence of metastatic infiltration.
• Poorly controlled hypertension.
• Previous exposure to any investigational agent within 4 weeks prior to administration of study drug or planned receipt during the study period.
• High likelihood of early withdrawal or interruption of the study.
• Participants who refuse to give informed consent.
• Women who are pregnant, lactating or not using a medically approved birth control.
• Life expectancy \<12 months.

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

Research Facility

Paris, France

Location

Research Facility

Erlangen, Germany

Location

Research Facility

Derby, United Kingdom

Location

Research Facility

London, United Kingdom

Location

Related Publications (1)

• Macdougall IC, Rossert J, Casadevall N, Stead RB, Duliege AM, Froissart M, Eckardt KU. A peptide-based erythropoietin-receptor agonist for pure red-cell aplasia. N Engl J Med. 2009 Nov 5;361(19):1848-55. doi: 10.1056/NEJMoa074037.

  PMID: 19890127 RESULT

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Red-Cell Aplasia, Pure

Interventions

peginesatide; hematide

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

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: April 13, 2006
• First Posted: April 17, 2006
• Study Start: April 6, 2006
• Primary Completion: October 24, 2016
• Study Completion: October 31, 2016
• Last Updated: March 14, 2019
• Results First Posted: March 14, 2019

Record last verified: 2018-11

Locations

GB (2); FR (1); DE (1)