Clinical Trial Details
| Trial ID: | L1021 |
| Source ID: | NCT00994318 |
| Associated Drug: | Fcm (Ferric Carboxymaltose) High Ferritin Target |
| Title: | Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) |
| Acronym: | FIND-CKD |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00994318/results |
| Conditions: | Iron Deficiency Anaemia|Chronic Kidney Disease |
| Interventions: | DRUG: FCM (Ferric carboxymaltose) high ferritin target|DRUG: FCM (Ferric carboxymaltose) low ferritin target|DRUG: Oral Iron (Ferrous sulphate) |
| Outcome Measures: | Primary: Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger, Endpoint reported number of participants with/without events and was reached: * First time of initiation of additional or alternative anaemia management, * First time the subject reached the Hb trigger. 3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order: 1. FCM (high ferritin target) compared with oral iron. 2. FCM (high ferritin target) compared with FCM (low ferritin target). 3. FCM (low ferritin target) compared with oral iron. Sensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management: 1. Without taking into account the Hb trigger. 2. Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data. 3. Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory., Up to 1 year after baseline | |
| Sponsor/Collaborators: | Sponsor: Vifor Pharma | Collaborators: American Regent, Inc.|ICON Clinical Research |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 626 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2009-12 |
| Completion Date: | 2014-02 |
| Results First Posted: | 2014-05-07 |
| Last Update Posted: | 2014-05-20 |
| Locations: | Trial Management Associates, Wilmington, North Carolina, 28401, United States|Gosford Hospital - Renal Research, Gosford, 2250, Australia|Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin IV, Innsbruck, 6020, Austria|RHMS Baudour - Department of Nephrology and Dialysis, Baudour, 7331, Belgium|Nemocnice s poliklinikou v Novem Jicine, p.o. p.o. Interni oddeleni - nefrologie a dialyza, Novy Jicin, 74101, Czech Republic|Lillebalt Frederica Sygehus Department of Nephrology, Frederica, 7000, Denmark|CHU grenoble - Service de Nephrologie, Grenoble Cedex, 38043, France|Praxis Dr. Kraatz, Demmin, 17109, Germany|General Hospital of Arta - Nephrology Department, Arta, 47100, Greece|Ospedali Riuniti Anzio-Nettuno ASL ROMA H U.O. Nefrologia e Dialisi, Anzio, 00042, Italy|Meander Medisch Centrum - Locatie Amersfoort Lichtenberg, Amersfoort, 3816 CP, Netherlands|St. Olav's Hospital, Trondheim, 7006, Norway|Miedzyleski Szpital Spec. Oddzial I Wewnetrzny I Nefrologii, Warszawa, 04-749, Poland|Hospital Santa Maria - Nefrologia, Lisboa, 1649-035, Portugal|Spitalul Clinic de Nefrologie"Dr Carol Davila", Bucuresti, 010731, Romania|Hospital Universitario Marqués de Valdecilla - Servicio de Nefrología, Santander, 39008, Spain|Karolinska University Hospital, Stockholm, 141, Sweden|Cukurova University Medical Faculty Balcali Hospital - Department of Nephrology, Adana, 01330, Turkey|King's College Hospital, London, SE5 9RS, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00994318 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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