Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation

ConditionKidney Transplant; Complications

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorShahid Beheshti University of Medical Sciences

About this trial

Cornerstone immunosuppressive therapy currently relies on immediate-release tacrolimus, a calcineurin inhibitor (CNI) that is potentially nephrotoxic and is more diabetogenic than cyclosporine A. A new formulation of tacrolimus has been launched: an extended-release formulation (Advagraf®/Astagraf XL®, Astellas company).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All Kidney transplant recipients

Disqualifiers

Kidney-Pancreas transplant BMI>30 cPRA>0%

Trial design

Design model

Parallel

Treatments tested in this trial

Rapamune Pill
Drug
Rapamiune Tablet 1mg daily plus Advograf plus prednisolone

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Standard of careNo intervention 0 interventions

Group B: InterventionOther 1 intervention

Trial outcomes

Primary outcomes

Kidney function

gfr measurement

Time frame

through study completion, an average of 1 year

Post-transplant viral Infections

Number of participents with positive blood tests of CMV and BK as assessed by PCR

Time frame

through study completion, an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shahid Beheshti University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

Apply now