A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.
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|ClinicalTrials.gov Identifier: NCT00605345|
Recruitment Status : Completed
First Posted : January 31, 2008
Results First Posted : August 5, 2016
Last Update Posted : September 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: Darbepoetin alfa Drug: methoxy polyethylene glycol-epoetin beta [Mircera]||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera Versus Darboepoetin Alfa for the Maintenance of Haemoglobin Levels in Renal Transplant Recipients With Chronic Renal Anaemia.|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
|Experimental: CERA Treatment Once Monthly||
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc 4-weekly (starting dose)
|Active Comparator: Darbepoetin Alfa Once Biweekly||
Drug: Darbepoetin alfa
- The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range [ Time Frame: Weeks 16-28 ]Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 - 12 g/dL.
- Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP) [ Time Frame: Baseline to 28 weeks ]Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline.
- Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 16-28 ]
- Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 16-28 ]Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.
- Percentage of Participants Needing Dose Adjustments [ Time Frame: Up to 28 weeks ]Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).
- Incidence of RBC Transfusions [ Time Frame: Up to 28 weeks ]Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605345
|Badalona, Barcelona, Spain, 08915|
|Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Santander, Cantabria, Spain, 39008|
|Córdoba, Cordoba, Spain, 14004|
|La Coruna, La Coruña, Spain, 15006|
|Santiago de Compostela, La Coruña, Spain, 15706|
|Barakaldo, Vizcaya, Spain, 48903|
|Galdakao, Vizcaya, Spain, 48960|
|Alicante, Spain, 03010|
|Badajoz, Spain, 06080|
|Barcelona, Spain, 08003|
|Barcelona, Spain, 08025|
|Barcelona, Spain, 08036|
|Ciudad Real, Spain, 13005|
|Granada, Spain, 18014|
|Madrid, Spain, 28007|
|Madrid, Spain, 28040|
|Madrid, Spain, 28041|
|Madrid, Spain, 28222|
|Valencia, Spain, 46017|
|Valladolid, Spain, 47005|
|Study Director:||Clinical Trials||Hoffmann-La Roche|