A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048048
First received: October 24, 2002
Last updated: June 10, 2013
Last verified: June 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-label Study of the Effect of Different Dosing Intervals of Subcutaneous Mircera on Hemoglobin Level/Correction in Patients With Chronic Renal Anemia |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Hemoglobin levels\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hematocrit, reticulocyte count. Vital signs, adverse events, laboratory values\n\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 65 |
| Study Start Date: | March 2002 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
| Experimental: 2 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
| Experimental: 3 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
| Experimental: 4 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
| Experimental: 5 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
| Experimental: 6 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
| Experimental: 7 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
| Experimental: 8 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
| Experimental: 9 |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- not receiving renal replacement therapy.
Exclusion Criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048048
Locations
| United States, Alabama | |
| Birmingham, Alabama, United States, 35211 | |
| United States, California | |
| San Diego, California, United States, 92103-8342 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48202-2689 | |
| Detroit, Michigan, United States, 48236 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89106 | |
| Reno, Nevada, United States, 89434 | |
| United States, New York | |
| Mineola, New York, United States, 11501 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97201-2940 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| France | |
| Colmar, France, 68024 | |
| Paris, France, 75018 | |
| Paris, France, 75475 | |
| Mexico | |
| Mexico City, Mexico, 14000 | |
| Monterrey, Mexico, 64710 | |
| Poland | |
| Gdansk, Poland, 80-211 | |
| Krakow, Poland, 31-501 | |
| Wroclaw, Poland, 50-417 | |
| United Kingdom | |
| Belfast, United Kingdom, BT9 7LJ | |
| London, United Kingdom, SE22 8PT | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00048048 History of Changes |
| Other Study ID Numbers: | BA16528 |
| Study First Received: | October 24, 2002 |
| Last Updated: | June 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Anemia Renal Insufficiency, Chronic Hematologic Diseases |
Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013