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

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Primary Purpose

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Tacrolimus

Rapamycin

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring Renal function, Serum creatinine, Immunosuppression, Rejection

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Complejo Hospitalario Universitario de Santiago
Hospital General Universitario Gregorio Marañón
Hospital Universitario Ramón y Cajal
Hospital Universitario 12 de Octubre
Hospital Universitario de Canarias
Hospital Universitario Marqués de Valdecilla
Hospital Universitario La Fe

Outcomes

Primary Outcome Measures

Serum creatinine at 6 months

Secondary Outcome Measures

Calculated creatinine clearance (Cockroft Gault)

Acute rejection rate at 6 months and time until first rejection

Patient and graft survival at 6 months

Rate and length of the delay in the graft function defined as dialysis in the first week post-transplant

Treatment failure at 6 months

Full Information

NCT ID

NCT00290069

First Posted

February 9, 2006

Last Updated

May 14, 2007

Sponsor

Sociedad Andaluza de Trasplantes de Organos y Tejidos

1. Study Identification

Unique Protocol Identification Number

NCT00290069

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2006

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sociedad Andaluza de Trasplantes de Organos y Tejidos

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Diseases, Graft Rejection

Keywords

Renal function, Serum creatinine, Immunosuppression, Rejection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

94 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tacrolimus

Intervention Type

Drug

Intervention Name(s)

Rapamycin

Primary Outcome Measure Information:

Title

Serum creatinine at 6 months

Secondary Outcome Measure Information:

Title

Calculated creatinine clearance (Cockroft Gault)

Title

Acute rejection rate at 6 months and time until first rejection

Title

Patient and graft survival at 6 months

Title

Rate and length of the delay in the graft function defined as dialysis in the first week post-transplant

Title

Treatment failure at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miguel A Gonzalez Molina, MD

Organizational Affiliation

Sociedad Andaluza de Trasplantes de Organos y Tejidos

Official's Role

Principal Investigator

Facility Information:

Facility Name

Complejo Hospitalario Universitario de Santiago

City

Santiago de Compostela

State/Province

La Coruña

ZIP/Postal Code

15706

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rafael Romero, MD

First Name & Middle Initial & Last Name & Degree

Rafael Romero, MD

Facility Name

Hospital General Universitario Gregorio Marañón

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fernando Anaya, MD

First Name & Middle Initial & Last Name & Degree

Fernando Anaya, MD

Facility Name

Hospital Universitario Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roberto Marcén, MD

First Name & Middle Initial & Last Name & Degree

Roberto Marcén, MD

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José L Morales, MD

First Name & Middle Initial & Last Name & Degree

José L Morales, MD

Facility Name

Hospital Universitario de Canarias

City

Santa Cruz de Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Domingo Hernández, MD

First Name & Middle Initial & Last Name & Degree

Domingo Hernández, MD

Facility Name

Hospital Universitario Marqués de Valdecilla

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan C Ruiz San Millán, MD

First Name & Middle Initial & Last Name & Degree

Juan C Ruiz San Millán, MD

Facility Name

Hospital Universitario La Fe

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaime Sánchez Plumed, MD

First Name & Middle Initial & Last Name & Degree

Jaime Sánchez Plumed, MD

Kidney Diseases, Graft Rejection

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial