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Sponsored by: |
Sociedad Andaluza de Trasplantes de Organos y Tejidos |
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Information provided by: | Sociedad Andaluza de Trasplantes de Organos y Tejidos |
ClinicalTrials.gov Identifier: | NCT00290069 |
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.
Condition | Intervention | Phase |
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Kidney Diseases Graft Rejection |
Drug: Tacrolimus Drug: Rapamycin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparative Study of Tacrolimus and Rapamycin to Evaluate the Renal Function in Patients Older Than 50 Years, Receptors of a Kidney From a Donor Older Than 55 Years in a Mycophenolate Mofetil and Daclizumab Immunosuppressor Regime |
Estimated Enrollment: | 94 |
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 doses to prevent over-immunosuppression in a population with a theoretic minor immune response.
On the other hand, the delay in the introduction of calcineurin inhibitors will prevent increasing the risk of early graft dysfunction allowing the highest post-transplant renal recovery in organs with less operative mass and greater sensibility to the nephrotoxic effect of these drugs.
The results of several studies confirm the goodness of regimes that include low doses of calcineurin inhibitors, delay their introduction or avoid them.
Nevertheless, although it is standard practice to evaluate the effectiveness of the regimes for a time to assure, with certainty, the response to the treatments, these follow-ups are still relatively short to assure the efficacy for a long-term study and to detect the problems. The studies with a high number of patients and long follow-up periods are difficult, so several authors have proposed different alternatives of control in a short-term study that could be useful as surrogate markers or predictive efficacy variables for the long term.
If the drug or study regime is efficient, the observed change after the transplantation surgery will have to be fast and objective. The increase of serum creatinine between 6 and 12 months post-transplant is a reliable marker of graft failure risk, and the magnitude of the serum creatinine change in these months is a marker of the relationship with long-term survival. For that reason, renal function (serum creatinine) is included as a main efficacy variable.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who the investigator thinks need a treatment with any medication listed below:
Spain | |
Hospital Universitario Ramón y Cajal | |
Madrid, Spain, 28034 | |
Hospital Universitario 12 de Octubre | |
Madrid, Spain, 28041 | |
Hospital General Universitario Gregorio Marañón | |
Madrid, Spain, 28007 | |
Hospital Universitario de Canarias | |
Santa Cruz de Tenerife, Spain, 38320 | |
Hospital Universitario Marqués de Valdecilla | |
Santander, Spain, 39008 | |
Hospital Universitario La Fe | |
Valencia, Spain, 46009 | |
Spain, La Coruña | |
Complejo Hospitalario Universitario de Santiago | |
Santiago de Compostela, La Coruña, Spain, 15706 |
Principal Investigator: | Miguel A Gonzalez Molina, MD | Sociedad Andaluza de Trasplantes de Organos y Tejidos |
Study ID Numbers: | SATOT42005, EudraCT number: 2005-001854-25, ALHAMBRA |
Study First Received: | February 9, 2006 |
Last Updated: | May 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00290069 |
Health Authority: | Spain: Spanish Agency of Medicines |
Renal function Serum creatinine Immunosuppression Rejection |
Sirolimus Urologic Diseases Clotrimazole Miconazole Daclizumab |
Tioconazole Mycophenolate mofetil Tacrolimus Kidney Diseases |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |