Evaluaion the Short Term Effects of Advograf Plus Rapamiu... | NCT07033858

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

NCT07033858

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Recruiting

Last Update Posted

Jun 24, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Kidney Transplant; Complications

Interventions

Rapamune Pill

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Actual

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

Jul 1, 2026Estimated

First Submitted Date

May 27, 2025

First Submission Date that Met QC Criteria

Jun 14, 2025

First Posted Date

Jun 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2025

Last Update Posted Date

Jun 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

nooshin dalili, assistant professor, Shahid Beheshti University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shahid Beheshti University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of care	No Intervention	Advograf plus Cellcept plus Prednisolone
Intervention	Other	Advograf plus Rapamiune plus Prednisolone	Drug: Rapamune Pill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rapamune Pill	Drug	Rapamiune Tablet 1mg daily plus Advograf plus prednisolone	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All Kidney transplant recipients

Exclusion Criteria:

Kidney-Pancreas transplant BMI>30 cPRA>0%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
PI	Contact	00989122404331		dr.nooshindalili@gmail.com

Overall Officials

Name	Affiliation	Role
Dalili	SBMU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nooshin Dalili	Recruiting	Tehran		1666663421	Iran

Intervention Browse Module

MeSH Terms

ID	Term
D020123	Sirolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided