Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00436995
First received: February 15, 2007
Last updated: January 20, 2011
Last verified: January 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease |
Drug: Darbepoetin Alfa |
Phase 3 |
| 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 Multicentre, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis. |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period. [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Q2W doses over duration of study. [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
- Hb values during the evaluation period. [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
- adverse events during study [ Time Frame: 33 weeks ] [ Designated as safety issue: Yes ]
- Hb Rate of Rise during study and excursions above 14g/dL [ Time Frame: 33 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 114 |
| Study Start Date: | April 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Single |
Drug: Darbepoetin Alfa
Administered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Receiving dialysis for 3 months or more before enrollment.
- The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL
- Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment
- Adequate iron stores (serum ferritin equal to or greater than 100 ug/L
Exclusion Criteria:
- Uncontrolled hypertension
- Prior history of Cardiovascular Incidents 12 weeks prior to enrollment
- Other hematological disorders
- Upper or lower GI bleed within the prior 6 months
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00436995 History of Changes |
| Other Study ID Numbers: | 20050210 |
| Study First Received: | February 15, 2007 |
| Last Updated: | January 20, 2011 |
| Health Authority: | Austria: Secretariat of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: Ministry of Health |
Keywords provided by Amgen:
|
Dialysis Anaemia |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
Darbepoetin alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013