Efficacy and Safety of Peginesatide in the Treatment of Anemia in Patients With Chronic Kidney Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00314795
First received: April 13, 2006
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate the ability of peginesatide 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).


Condition Intervention Phase
Anemia
Chronic Kidney Disease
Chronic Renal Failure
Pure Red Cell Aplasia
Drug: peginesatide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Investigate the Efficacy and Safety of Peginesatide in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Proportion of participants who 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of red blood cell transfusions during the 26 week pre-treatment period (prior to enrollment) and during 13- and 26 week intervals during the study. [ Time Frame: 26 weeks prior to enrollment to end of study ] [ Designated as safety issue: No ]
  • Time to initial achievement of hemoglobin 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. [ Time Frame: While On Study ] [ Designated as safety issue: No ]
  • Proportion of participants with red blood cell transfusions during the 26 week pre-treatment period (prior to enrollment) and during 13- and 26 week intervals during the study. [ Time Frame: 26 weeks prior to enrollment to end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2006
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peginesatide
Peginesatide dose administered subcutaneously once every 4 weeks. The frequency of each injection and the dose may be adjusted based on the participant's hemoglobin response and the ability to maintain a hemoglobin level in the range of 10.0-12.0 g/dL.
Drug: peginesatide
Other Names:
  • Omontys
  • Hematide
  • AF37702 Injection

Detailed Description:

This is an open-label treatment study; all participants enrolled into the study will receive peginesatide. Participants with CKD with documented antibody-mediated PRCA, a hemoglobin level < 10 grams per deciliter (g/dL) (without an erythropoiesis stimulating agent [ESA]), and who meet the eligibility criteria will be enrolled. It is anticipated that up to 40 patients will be enrolled in the trial.

The first group of 5 participants will receive a starting dose of 0.05 milligram per kilogram (mg/kg), administered every 4 weeks (for this study, 1 month is defined as 4 weeks). Based on the assessment of the dose response in this initial group of 5 participants, the starting dose in subsequent participants may be increased. The dose and frequency of peginesatide will be modified based on hemoglobin response in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who have confirmed antibody-mediated PRCA are potentially eligible for enrollment into this study.
  • Participants must be ≥ 18 years old at the time of consent.
  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314795

Locations
France
Research Facility
Paris, France
Germany
Research Facility
Erlangen, Germany
United Kingdom
Research Facility
Derby, United Kingdom
Research Facility
London, United Kingdom
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Publications:
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00314795     History of Changes
Other Study ID Numbers: AFX01-06, 2005-004944-30
Study First Received: April 13, 2006
Last Updated: December 2, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda:
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

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Red-Cell Aplasia, Pure
Renal Insufficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014