Clinical trial NCT00605345: A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \> or = 18 years of age;
* kidney transplant recipients with stage 3 or stage 4 chronic kidney disease;
* functioning graft of \> 6 months and \< 10 years after kidney transplantation, with no signs of acute rejection;
* stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension;
* significant acute or chronic bleeding;
* need for dialysis therapy expected in next 6 months.

Primary outcomes:
measure: The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range
timeFrame: Weeks 16-28
Secondary outcomes:
measure: Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)
timeFrame: Baseline to 28 weeks
measure: Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)
timeFrame: Weeks 16-28
measure: Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)
timeFrame: Weeks 16-28
measure: Percentage of Participants Needing Dose Adjustments
timeFrame: Up to 28 weeks
measure: Incidence of RBC Transfusions
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: Badalona
country: Spain
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Santander
country: Spain
state: Cantabria
city: Córdoba
country: Spain
state: Cordoba
city: La Coruna
country: Spain
state: La Coruña
city: Santiago de Compostela
country: Spain
state: La Coruña
city: Barakaldo
country: Spain
state: Vizcaya
city: Galdakao
country: Spain
state: Vizcaya
city: Alicante
country: Spain
city: Badajoz
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Ciudad Real
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Campistol JM, Carreno A, Morales JM, Pallardo L, Franco A, Navarro D, Grinyo JM, Montenegro J, Sanchez Fructuoso AI, Romero R, Guirado L, Arias M; TIVOLI Study Group. Once-monthly pegylated epoetin Beta versus darbepoetin alfa every two weeks in renal transplant recipients: a randomized trial. Transplantation. 2013 Jan 27;95(2):e6-e10. doi: 10.1097/TP.0b013e3182782f3a. No abstract available.