Study Evaluating Sirolimus in the Treatment of Kidney Transplant

Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00282217

Enrollment

100

Registered

2006-01-25

Start date

2006-08-31

Completion date

Unknown

Last updated

2007-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Diseases, Kidney Failure

Keywords

Kidney Failure, Kidney Transplant, Graft Rejection, Kidney Transplantation

Brief summary

The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.

Interventions

DRUGSirolimus

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Renal transplantation * Biopsy-confirmed chronic rejection * Treatment with mofetil mycophenolate among cyclosporine or tacrolimus

Exclusion criteria

* Transplant of any organ other than the kidney * Current important infection * Acute rejection within 12 weeks prior to inclusion

Design outcomes

Primary

Measure	Time frame
Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus	—

Secondary

Measure	Time frame
Histological parameters at 12 months	—
Cumulative incidence of biopsy-confirmed acute rejection at 12 months	—
Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026