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

NCT ID: NCT07033858

Last Updated: 2025-06-24

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-07-01

Brief Summary

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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).

Detailed Description

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This study wants to assess the efficacy of an extended-release formulation of tacrolimus (Advagraf®/Astagraf XL®) used in conjunction with an mTOR-inhibitor agent (sirolimus ) instead of MMF to evaluate the hypothesis that this regimen is associated with good allograft outcome, and might also prevent late-onset cytomegalovirus infection. Advagraf®-based immunosuppression given to de novo kidney-transplant recipients may also increase patients' adherence to treatment due to once-daily usage of the drug.

Conditions

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Kidney Transplant; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard of care

Advograf plus Cellcept plus Prednisolone

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Advograf plus Rapamiune plus Prednisolone

Group Type OTHER

Rapamune Pill

Intervention Type DRUG

Rapamiune Tablet 1mg daily plus Advograf plus prednisolone

Interventions

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Rapamune Pill

Rapamiune Tablet 1mg daily plus Advograf plus prednisolone

Intervention Type DRUG

Other Intervention Names

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Sirolimus

Eligibility Criteria

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Inclusion Criteria

* All Kidney transplant recipients

Exclusion Criteria

* Kidney-Pancreas transplant BMI\>30 cPRA\>0%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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nooshin dalili

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalili

Role: PRINCIPAL_INVESTIGATOR

SBMU

Locations

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Nooshin Dalili

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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PI

Role: CONTACT

00989122404331

Facility Contacts

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Nooshin Dalili, Dr

Role: primary

00989122404331

Other Identifiers

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SBMU-1404-2

Identifier Type: -

Identifier Source: org_study_id

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