Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00290069
Recruitment Status : Unknown
Verified February 2006 by Sociedad Andaluza de Trasplantes de Organos y Tejidos.
Recruitment status was:  Not yet recruiting
First Posted : February 10, 2006
Last Update Posted : May 15, 2007
Information provided by:
Sociedad Andaluza de Trasplantes de Organos y Tejidos

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, 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 or disease Intervention/treatment Phase
Kidney Diseases Graft Rejection Drug: Tacrolimus Drug: Rapamycin Phase 4

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Primary Outcome Measures :
  1. Serum creatinine at 6 months

Secondary Outcome Measures :
  1. Calculated creatinine clearance (Cockroft Gault)
  2. Acute rejection rate at 6 months and time until first rejection
  3. Patient and graft survival at 6 months
  4. Rate and length of the delay in the graft function defined as dialysis in the first week post-transplant
  5. Treatment failure at 6 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00290069

Layout table for location information
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain, 15706
Contact: Rafael Romero, MD         
Principal Investigator: Rafael Romero, MD         
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Contact: Fernando Anaya, MD         
Principal Investigator: Fernando Anaya, MD         
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Contact: Roberto Marcén, MD         
Principal Investigator: Roberto Marcén, MD         
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Contact: José L Morales, MD         
Principal Investigator: José L Morales, MD         
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain, 38320
Contact: Domingo Hernández, MD         
Principal Investigator: Domingo Hernández, MD         
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Contact: Juan C Ruiz San Millán, MD         
Principal Investigator: Juan C Ruiz San Millán, MD         
Hospital Universitario La Fe
Valencia, Spain, 46009
Contact: Jaime Sánchez Plumed, MD         
Principal Investigator: Jaime Sánchez Plumed, MD         
Sponsors and Collaborators
Sociedad Andaluza de Trasplantes de Organos y Tejidos
Layout table for investigator information
Principal Investigator: Miguel A Gonzalez Molina, MD Sociedad Andaluza de Trasplantes de Organos y Tejidos
Layout table for additonal information Identifier: NCT00290069    
Other Study ID Numbers: SATOT42005
EudraCT number: 2005-001854-25
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: May 15, 2007
Last Verified: February 2006
Keywords provided by Sociedad Andaluza de Trasplantes de Organos y Tejidos:
Renal function
Serum creatinine
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents