Short-term effects of once-daily Advagraf plus sirolimus after kidney transplant
Investigating the Effect of Low-dose Extended-release Tacrolimus and Sirolimus on the Short-term Outcomes of Allograft Kidney Transplantation
NA · Shahid Beheshti University of Medical Sciences · NCT07033858
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.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shahid Beheshti University of Medical Sciences (other) |
| Locations | 1 site (Tehran) |
| Trial ID | NCT07033858 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All Kidney transplant recipients Exclusion Criteria: * Kidney-Pancreas transplant BMI\>30 cPRA\>0%
Where this trial is running
Tehran
- Nooshin Dalili — Tehran, Iran (RECRUITING)
Study contacts
- Principal investigator: Dalili — SBMU
- Study coordinator: PI
- Email: dr.nooshindalili@gmail.com
- Phone: 00989122404331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Transplant, Complications