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

Status:

UNKNOWN

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

Lead Sponsor:

Sociedad Andaluza de Trasplantes de Organos y Tejidos

Conditions:

Kidney Diseases

Graft Rejection

Eligibility:

All Genders

50+ years

Phase:

PHASE4

Brief 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, mycop...

Detailed Description

The study population characteristics raise the need to establish a treatment regime that assures suitable intensity immunosuppression to avoid the appearance of rejection episodes, but minimizes the d...

Eligibility Criteria

Inclusion

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

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

94 Patients enrolled

Trial Details

Trial ID

NCT00290069

Last Update

May 15 2007

Active Locations (7)

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Page 1 of 2 (7 locations)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain, 39008

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, Spain, 15706

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain, 28007