Phase 2 Study of Darbepoetin Alfa Extended Dosing
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00527215
First received: September 6, 2007
Last updated: May 21, 2009
Last verified: May 2009
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Purpose
Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.
| Condition | Intervention | Phase |
|---|---|---|
|
Pre-Dialysis |
Drug: darbepoetin alfa |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of Darbepoetin Alfa Administered Once Every Four Weeks in Chronic Renal Insufficiency (CRI) Subjects With Anemia |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks [ Time Frame: Study weeks 21 - 29 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks. [ Time Frame: Entire study ] [ Designated as safety issue: Yes ]
| Enrollment: | 98 |
| Study Start Date: | March 2002 |
| Study Completion Date: | October 2003 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: darbepoetin alfa |
Drug: darbepoetin alfa
starting dose determined by calculating a subject's total dose in the month preceding enrollment. Administered QM for 25 weeks. Change made as necessary to maintain a hemoglobin concentration within the target range os 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:
- Greater than or equal to 18 years of age
- CRI with a creatinine clearance of greater than 15 but less than 40 mL/min
- Stable once every other week darbepoetin alfa SC for at least 6 weeks
- Hb values during screening / baseline of 10.0 - 12.0 g/dL
- Serum B12 and folate levels above the lower limit of normal and iron replete
Exclusion Criteria:
- Receiving renal replacement therapy
- Uncontrolled hypertension
- Hyperparathyroidism
- Major surgery, active inflammatory disease, receiving antibiotics, HIV-positive
- Current malignancy
- Pregnant or breast-feeding
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00527215 History of Changes |
| Other Study ID Numbers: | 20010212 |
| Study First Received: | September 6, 2007 |
| Last Updated: | May 21, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency, Chronic Renal Insufficiency Kidney Diseases Urologic Diseases |
Darbepoetin alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013