Study to Evaluate Safety and Immunologic Biomarker of Rapamune in Patients With Stable Renal Transplant Recipient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

For patients who meet the inclusion criteria and who agree to participate in this study, the investigators sampled peripheral blood 10cc and performed the analysis for immunologic profile just before the conversion of immune suppressant. At 1 month, 6 month, and 1 year from the conversion of Immune suppressant (CNI to rapamune), the investigators performed tha analysis fo immune profile again. During the study period, the interval of the visit of subclinic and the kinds of laboratory test (Blood and urine test) would not change compared to before the start of this study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients

NCT05193565

Kidney Transplantation

UNKNOWN PHASE4

Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney Transplantation

NCT00811915

Kidney Transplantation

COMPLETED PHASE3

Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients

NCT01680952

Kidney Transplant Patients

COMPLETED PHASE4

Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients

NCT00866879

Renal Transplant Rejection

COMPLETED PHASE4

Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients

NCT00037531

Graft vs Host Disease Kidney Transplantation

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Rejection of Renal Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sirolimus

Beginning on day, an initial maintenance dose of 2mg/day should be given. A trough level should be obtained between days 3 and 8, and the daily dose of sirolimus should be adjusted thereafter.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Renal transplant recipient who has passed at least 10 years
2. No acute rejection episode during the previous 6 months
3. No change of prescription of immune suppressants
4. Normal allograft function (MDRD eGFR \> 80 mL/min/1.73 m2)
5. Change of allograft function less than 10 % of baseline value durant the previous 1 year
6. No proteinuria and hematuria

Exclusion Criteria

1. Patients who donut want to participate in this study
2. Patients who should continue immune suppressant due to another cause (e/g combined autoimmune disease)

Eligible Sex

ALL

Accepts Healthy Volunteers

No