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NCT00077766
A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.
Phase 3 trial testing Darbepoetin alfa in Anemia in 313 participants. Completed in 1 August 2005.
1 August 2005
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 313 |
| Start date | 1 March 2004 |
| Primary completion | 1 August 2005 |
| Estimated completion | 1 August 2005 |
| Sites | 48 locations across Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany |
Drugs / interventions tested
- Darbepoetin alfa (DARBEPOETIN ALFA) — full drug profile →
- methoxy polyethylene glycol-epoetin beta [Mircera] — full drug profile →
Conditions studied
- Anemia — all drugs for Anemia →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
18 and older, any sex, with Anemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period
Time frame: Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)
A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline (Week -4 to Week -1) and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were take
Sponsor's own description
This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study.
Canaud B, Mingardi G, Braun J, Aljama P, et al · · 2008 · cited 46× · PMID 18586762 · DOI 10.1093/ndt/gfn320
Verify or expand the search:
- PubMed search for NCT00077766
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Darbepoetin alfa
Trials testing the same drug.
- NCT04313153 — Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Mainten · Phase 3 · completed
- NCT03992066 — Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia · Phase 1 · completed
- NCT03446612 — Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat · Phase 2 · terminated
- NCT03543657 — Maintenance Treatment of Renal Anemia in Dialysis Subjects · Phase 3 · completed
- NCT03439137 — Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated W · Phase 3 · completed
Other recruiting trials for Anemia
Currently open trials in the same condition.
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- NCT06968936 — Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy · NA · recruiting
- NCT07328191 — Quality of Life-Guided Transfusion in Refractory MDS or AML · NA · recruiting
- NCT07315295 — Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya · NA · recruiting
- NCT07400796 — Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia · recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
- NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
- NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
- NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
- NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
- NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00077766 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
- Last refreshed: 16 September 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00077766.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing