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:
Affymax
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00314795
First received: April 13, 2006
Last updated: April 9, 2013
Last verified: April 2013
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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:
MedlinePlus related topics:
Anemia
Blood Transfusion and Donation
Chronic Kidney Disease
Kidney Failure
Drug Information available for:
Peginesatide
U.S. FDA Resources
Further study details as provided by Affymax:
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: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (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:
|
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
Affymax
Investigators
| Study Director: | Affymax | Affymax |
More Information
Publications:
| Responsible Party: | Affymax |
| ClinicalTrials.gov Identifier: | NCT00314795 History of Changes |
| Other Study ID Numbers: | AFX01-06, 2005-004944-30 |
| Study First Received: | April 13, 2006 |
| Last Updated: | April 9, 2013 |
| Health Authority: | France: Committee for the Protection of Personnes France: L’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 Affymax:
|
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 May 16, 2013