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

NCT ID: NCT00605345

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-07-31

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CERA Treatment Once Monthly

Group Type: EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type: DRUG

120, 200 or 360 micrograms sc 4-weekly (starting dose)

Darbepoetin Alfa Once Biweekly

Group Type: ACTIVE_COMPARATOR

Darbepoetin alfa

Intervention Type: DRUG

As prescribed

Interventions

Darbepoetin alfa

As prescribed

Intervention Type: DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

120, 200 or 360 micrograms sc 4-weekly (starting dose)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Alicante, Alicante, Spain

Badajoz, Badajoz, Spain

Badalona, Barcelona, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

L'Hospitalet de Llobregat, Barcelona, Spain

Santander, Cantabria, Spain

Ciudad Real, Ciudad Real, Spain

Córdoba, Cordoba, Spain

Granada, Granada, Spain

A Coruña, La Coruña, Spain

Santiago de Compostela, La Coruña, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Valencia, Valencia, Spain

Valladolid, Valladolid, Spain

Barakaldo, Vizcaya, Spain

Galdakao, Vizcaya, Spain

Countries

Spain

References

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Reference Type: DERIVED

PMID: 36791280 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23325012 (View on PubMed)

Other Identifiers

ML21058

Identifier Type: -

Identifier Source: org_study_id