Renal Function Optimization With Mycophenolate Mofetil (MMF) Immunosuppressor Regimes (ALHAMBRA)

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The main aim of this study is to compare the renal function (serum creatinine at 6 months) in the later introduction of tacrolimus or rapamycin based in immunosuppressor regimes with daclizumab, mycophenolate mofetil, and steroids in patients older than 50 years of age who are the recipients of a graft from donors aged 55 years and older.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sociedad Andaluza de Trasplantes de Organos y Tejidos
• Treatments: Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Both male and female patients older than 50 years who are primary recipients of a renal allograft from a donor older than 55 years.

• Patients who have given their consent previously to their participation in the study.

Exclusion Criteria:

• Recipients of a multi-organ transplant.

• Recipients of a transplant from a cadaveric donor with a cold ischemic time > 30 hours.

• Patients with a plasma renin activity (PRA) > 20% in 6 months previous to the inclusion.

• Breast-feeding, pregnant, or fertile women who do not use a reliable anticonceptive method before starting therapy with the study drug, during the therapy, and during the 4 months after the last dose of the drugs administered in the study.

• Patients with leukocyte count < 2.5 x 10^9/L, platelet count < 100 x 10^9/L, or haemoglobin < 6 g/dL in the inclusion time

• Patients with active hepatic illness evidence.

• Patients with active peptic ulcer.

• Patients with serious diarrhoea or any intestinal upset that may interfere in the absorption capability of oral medication, including diabetic patients with previously diagnosticated diabetic gastroenteropathy.

• Patients with evidence of active systemic infection that require the continued use of antibiotics or evidence of HIV infection or hepatitis B presence (positive HBs-Ag) or active chronic hepatitis C.

• Patients with malignancy history (except satisfactorily treated non- melanocytic localized skin cancer and cervix "in situ" carcinoma).

• Patients with history of psychologic disease that may interfere in the patients capability to understand the study requirements.

• Patients who the investigator thinks need a treatment with any medication listed below:

• Azathioprine,

• Methotrexate,

• Cyclofosfamide,

• Polyclonal or monoclonal anti-lymphocitaries antibodies (OKT3, ATG), used for the induction in patients with high immunologic risk,

• Basiliximab, and

• Other research drugs

• Known hypersensibility or complete contraindication of any of the drugs administered in the study context or any other substance present in the study drugs.