Efficacy and Safety of Peginesatide in the Treatment of Anemia in Patients With Chronic Kidney Disease
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| ClinicalTrials.gov Identifier: NCT00314795 |
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Recruitment Status :
Completed
First Posted : April 17, 2006
Last Update Posted : November 30, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anemia Chronic Kidney Disease Chronic Renal Failure Pure Red Cell Aplasia | Drug: peginesatide | Phase 2 |
This is an open-label treatment study; all patients enrolled into the study will receive AF37702 Injection. Hematologic data prior to treatment with AF37702 Injection will be compared to values obtained during treatment with AF37702 Injection (see Section 6.2).
CKD patients with documented antibody-mediated PRCA, hemoglobin level < 10 g/dL (without ESA therapy) or require transfusions to maintain this hemoglobin level, 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 patients will receive a starting dose of 0.05 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 patients, it is recommended the starting dose in subsequent patients be increased to 0.075 mg/kg. The individual dose of AF37702 Injection will be modified based on hemoglobin levels. Dose adjustments will be made in order to achieve and maintain hemoglobin in the target range of 10.0-12.0 g/dL (see Section 5.4.1). The frequency of dosing may be decreased and dosing ultimately discontinued if Hgb is maintained within the target range. Due to the lack of treatment options in this population, more frequent dosing is justified in cases of a suboptimal response. If the Investigator determines that a patient has a suboptimal response despite dose increases, the frequency of injections may be increased up to once every other week, but the total dose may not exceed 0.35 mg/kg every 4 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 22 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | April 2006 |
| Actual Primary Completion Date : | October 2016 |
| Actual Study Completion Date : | October 2016 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: peginesatide
Other Names:
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- 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 ]
- 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 ]
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314795
| France | |
| Research Facility | |
| Paris, France | |
| Germany | |
| Research Facility | |
| Erlangen, Germany | |
| United Kingdom | |
| Research Facility | |
| Derby, United Kingdom | |
| Research Facility | |
| London, United Kingdom | |
| Study Director: | Medical Director | Takeda |
Publications of Results:
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT00314795 History of Changes |
| Other Study ID Numbers: |
AFX01-06 2005-004944-30 ( EudraCT Number ) |
| First Posted: | April 17, 2006 Key Record Dates |
| Last Update Posted: | November 30, 2016 |
| Last Verified: | November 2016 |
Keywords provided by Takeda:
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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:
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Anemia Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency |
Kidney Failure, Chronic Red-Cell Aplasia, Pure Hematologic Diseases Urologic Diseases |