A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.

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.

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; Drug: Darbepoetin alfa

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03010
  • Badajoz, Spain, 06080
  • Barcelona, Spain, 08036
  • Barcelona, Spain, 08003
  • Barcelona, Spain, 08025
  • Ciudad Real, Spain, 13005
  • Granada, Spain, 18014
  • Madrid, Spain, 28040
  • Madrid, Spain, 28041
  • Madrid, Spain, 28007
  • Madrid, Spain, 28222
  • Valencia, Spain, 46017
  • Valladolid, Spain, 47005
  • Barcelona
    • Badalona, Barcelona, Spain, 08915
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
  • Cantabria
    • Santander, Cantabria, Spain, 39008
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
  • La Coruña
    • La Coruna, La Coruña, Spain, 15006
    • Santiago de Compostela, La Coruña, Spain, 15706
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
    • Galdakao, Vizcaya, Spain, 48960

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; As prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range	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.	Weeks 16-28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)	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.	Baseline to 28 weeks
Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)		Weeks 16-28
Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)	Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.	Weeks 16-28
Percentage of Participants Needing Dose Adjustments	Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).	Up to 28 weeks
Incidence of RBC Transfusions	Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).	Up to 28 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: January 18, 2008
• First Submitted That Met QC Criteria: January 18, 2008
• First Posted (ESTIMATE): January 31, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2016
• Last Update Submitted That Met QC Criteria: August 17, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Darbepoetin alfa
• Other Study ID Numbers: ML21058