Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT00290069
Status:
UNKNOWN
Last Update Posted:
2007-05-15
First Post:
2006-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Renal Function Optimization With Mycophenolate Mofetil (MMF) Immunosuppressor Regimes (ALHAMBRA)
Sponsor:
Sociedad Andaluza de Trasplantes de Organos y Tejidos
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2006-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: