Kidney Transplant; ComplicationsNCT07033858
Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation
A study testing Rapamune Pill in people with Kidney Transplant; Complications, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications
- What is being tested?
- Rapamune Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Kidney transplant recipients
Who cannot join
- Kidney-Pancreas transplant BMI>30 cPRA>0%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Nooshin Dalili
Tehran, 1666663421
Nooshin Dalili, Dr, 00989122404331, nooshindalili4@gmail.com
About this study
Official title: Investigating the Effect of Low-dose Extended-release Tacrolimus and Sirolimus on the Short-term Outcomes of Allograft Kidney Transplantation
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).
Read the detailed description
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
- Kidney Transplant; Complications
- Being tested
- Rapamune Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamune PillDrug
Also called Sirolimus
Rapamiune Tablet 1mg daily plus Advograf plus prednisolone
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Advograf plus Cellcept plus Prednisolone |
| Intervention | Other | Advograf plus Rapamiune plus Prednisolone Receives: Drug: Rapamune Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney function
gfr measurement
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
- Investigators
- Dalili, Principal investigator, SBMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033858
- Sponsor's protocol ID
- SBMU-1404-2
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Low-dose Extended-release Tacrolimus and Sirolimus on the Short-term Outcomes of Allograft Kidney Transplantation
- ClinicalTrials.gov ID
- NCT07033858
- Acronym / sponsor ID
- SBMU-1404-2
- Conditions
- Kidney Transplant; Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Advograf plus Cellcept plus Prednisolone |
| Intervention | Other | Drug: Rapamune PillAdvograf plus Rapamiune plus Prednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All Kidney transplant recipients
Key exclusion criteria (1 listed)
- Kidney-Pancreas transplant BMI>30 cPRA>0%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapamune PillAlso: SirolimusRapamiune Tablet 1mg daily plus Advograf plus prednisolone | Drug | Intervention |
Primary outcome
Kidney function
Time frame: through study completion, an average of 1 year
gfr measurement
Post-transplant viral Infections
Time frame: through study completion, an average of 1 year
Number of participents with positive blood tests of CMV and BK as assessed by PCR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dalili principal investigator
SBMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapamune Pill in people with Kidney Transplant; Complications, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PI (00989122404331, dr.nooshindalili@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney function (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.