Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Short-term effects of once-daily Advagraf plus sirolimus after kidney transplant

Official title: Investigating the Effect of Low-dose Extended-release Tacrolimus and Sirolimus on the Short-term Outcomes of Allograft Kidney Transplantation

Run by Shahid Beheshti University of Medical Sciences · NCT07033858 · Data updated 2026-11-12

This test tries once-daily extended-release tacrolimus (Advagraf) with sirolimus (Rapamune) in people after kidney transplant to see if it protects the new kidney, improves adherence, and lowers late cytomegalovirus risk.

More Kidney Transplant trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorShahid Beheshti University of Medical Sciences
Academic / other
Locations1 site (Tehran)
StatusRecruiting
StartedMarch 1, 2025
Main results expectedMarch 1, 2026
Study endsJuly 1, 2026
Registry record updatedJune 24, 2025
Trial IDNCT07033858 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are new kidney transplant recipients without a pancreas transplant, with BMI ≤ 30, no preexisting sensitization (cPRA = 0%), and who can attend the Tehran study site.

Probably not a fit

Patients with kidney–pancreas transplants, BMI > 30, any degree of sensitization (cPRA > 0%), or those unable to attend the Tehran site are unlikely to be eligible or to gain direct benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial gives de novo kidney transplant recipients a regimen of once-daily extended-release tacrolimus (Advagraf/Astagraf XL) combined with the mTOR inhibitor sirolimus (Rapamune) instead of standard mycophenolate (MMF). The study measures short-term outcomes including graft function, infection rates (notably late-onset CMV), and treatment adherence related to once-daily dosing. Key exclusions include kidney–pancreas transplants, BMI > 30, and any preexisting sensitization (cPRA > 0%). The protocol aims to determine whether this combination maintains good allograft outcomes while potentially reducing CNI-related toxicity and improving compliance.

Why it matters

Potential benefit: If successful, the regimen could maintain good graft function while improving medication adherence and possibly reducing late CMV infections.

How similar studies have gone: Extended-release tacrolimus has been used in other trials with comparable drug exposure and improved adherence, and mTOR inhibitors have shown some antiviral benefits, but combining Advagraf with sirolimus in de novo kidney recipients is less well established.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* All Kidney transplant recipients

Exclusion Criteria:

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

Where it's running

  • Nooshin Dalili
    Tehran, Iran
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.