Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation
Investigating the Effect of Low-dose Extended-release Tacrolimus and Sirolimus on the Short-term Outcomes of Allograft Kidney Transplantation
1 other identifier
interventional
50
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2025
CompletedFirst Submitted
Initial submission to the registry
May 27, 2025
CompletedFirst Posted
Study publicly available on registry
June 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedJune 24, 2025
June 1, 2025
1 year
May 27, 2025
June 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Kidney function
gfr measurement
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
through study completion, an average of 1 year
Study Arms (2)
Standard of care
NO INTERVENTIONAdvograf plus Cellcept plus Prednisolone
Intervention
OTHERAdvograf plus Rapamiune plus Prednisolone
Interventions
Rapamiune Tablet 1mg daily plus Advograf plus prednisolone
Eligibility Criteria
You may qualify if:
- All Kidney transplant recipients
You may not qualify if:
- Kidney-Pancreas transplant BMI\>30 cPRA\>0%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nooshin Dalili
Tehran, 1666663421, Iran
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dalili
SBMU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
May 27, 2025
First Posted
June 24, 2025
Study Start
March 1, 2025
Primary Completion
March 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
June 24, 2025
Record last verified: 2025-06