NCT01166724

TerminatedPhase 3

Renal Allograft Function and Histology Following Switching F...

The Cleveland Clinic Source

Study Stopped

Collaborator stopped study

Renal Allograft Function and Histology Following Switching From A Tacrolimus to Sirolimus (SRL)-Based Immunosuppression-

The Cleveland Clinic ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

09-702

Study Type

interventional

Actual enrollment (reported)

12

Locations

1 country

Sites

1

Timeline

Study Start

July 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2014

Actual (reported)

Study Completion

December 2014

Actual (reported)

Brief Summary

The investigators hypothesize that Tacrolimus (Tac) withdrawal from a Tac, MMF and steroid based triple therapy regimen leads to long term improved/stabilized graft function (glomerular filtration rate, GFR) primarily as a consequence of halting CNI-induced fibrogenetic processes that mediate loss of functioning renal tissue. The investigators further hypothesize that the underlying fibrotic mechanism is mediated by pathophysiologic processes that promote epithelial to mesenchymal transition (EMT) (mediated by TGF- ƒÒ) and that early therapeutic intervention may reverse this process (mediated by BMP-7)4. To address these hypotheses the investigators propose the following clinical and mechanistic aims: The investigators will test the hypothesis that switching from Tac to SRL in a Tac based triple therapy regimen with MMF and steroids in living and or deceased donor renal transplant recipients leads to improvement in allograft structure and function at 2 years post-transplantation. The investigators will test this hypothesis in an open label controlled trial where stable renal allograft recipients on Tac, MMF, prednisone maintenance immunosuppression will undergo renal biopsy at 3-4 months post-transplantation and will be randomized to either a) Remain on Tac, MMF and prednisone (CNI-maintenance) or b) switch the Tac to SRL and continue MMF and prednisone. The investigators will then compare biopsy derived measures of allograft fibrosis (CADI, Sirius Red, Banff Chronicity Index) and GFR in the two groups

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 12 participants
Study completion date: December 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 20, 2010
Actual (reported)
First Posted
July 21, 2010
Actual (reported)
Primary Completion
December 2014
Actual (reported)
Study Completion
December 2014
Actual (reported)
Results Posted
June 7, 2017
Actual (reported)

Last Updated: June 7, 2017
Status Verified: February 2017
Results QC Date: May 9, 2017
Last Update Submitted: May 9, 2017

Conditions

Kidney Transplant

Keywords

Kidney transplant

Outcome Measures

Primary Outcomes (1)

Biopsy-derived Measures of Fibrosis
The primary analyses will compare biopsy-derived measures of fibrosis in the Tac-maintenance and SRL groups using the t-test.
12 months

Secondary Outcomes (1)

Change in iGFR
12 months

Study Arms (2)

Sirolimus

ACTIVE COMPARATOR

patients will be switched from Tacrolimus to Sirolimus

Drug: SirolimusDrug: Tacrolimus

Tacrolimus

NO INTERVENTION

Patient will stay on Tacrolimus

Interventions

SirolimusDrug

Tacrolimus to Sirolimus

Sirolimus

TacrolimusDrug

dosage per trough level

Sirolimus

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Absence of clinical acute rejection in post-transplant period preceding randomization
HLA-mismatched solitary first and second kidney transplant recipients

Sponsors & Collaborators

The Cleveland Clinic
Otherlead
Pfizer
Industrycollaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

MeSH Terms

Interventions

SirolimusTacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Limitations and Caveats

Early termination; Sponsor discontinued the study for corporate reasons. No data analyzed.

Results Point of Contact

Title: Dr. Stuart Flechner
Organization: Cleveland Clinic

Study Officials

T Srinivas, MD
The Cleveland Clinic
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 21, 2010

Study Start

July 2010

Date type not reported

This date has not been verified as actual or estimated.

Phase 3

Terminated

NCT00223678

Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure

Phase 4Completed

NCT00302497

EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

Phase 3Unknown

NCT00275522

The Comparison of Three Different Immunosuppressant Regimens in Kidney Transplant Recipients.

Phase 4Completed

NCT06055608

Advancing Transplantation Outcomes in Children

Phase 2Recruiting

NCT04102943

Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.

Phase 4Completed

NCT04224350

Study to Evaluate the Efficacy and Safety of Tacrolimus in Kidney Transplant Recipients (BLOSSOM)

Phase 4Unknown

Absence of any degree of rejection (Banff 2007) on renal biopsy at 3-6 months(+/- 2 months) post-transplant.

Absence of post-transplant donor-specific antibody

You may not qualify if:

HLA-identical transplants
Contraindication or inability to undergo renal biopsy, like previous complications due to biopsies, anticoagulation, active infection, etc.
Positive flow cross match, sensitized recipient, presence of donor-specific antibody.
Rejection episode after transplantation, either cellular or humoral on for cause or renal biopsy.
Rejection present on pre-randomization renal biopsy.
Proteinuria greater than 0.3 gram/day
Native kidney disease biopsy proven or likely glomerulonephritis, primary or recurrent FSGS, MPGN or primary or recurrent membranous GN.
Hypertriglyceridemia \> 400 mg/dL (treated), LDL cholesterol \> 160 mg/dL while on optimal treatment.
WBC \< 2000/mm3, ANC \< 1000 mm3, Platelet count \< 100,000 mm3
Active wound issues.
Primary non-function.
Active BKV or CMV disease.
Evidence of recurrent disease.
Active infection
Pregnancy
+2 more criteria

Contact the study team to confirm eligibility.

Primary Completion

December 2014

Actual (reported)

Study Completion

December 2014

Actual (reported)

Last Updated

June 7, 2017

Results First Posted

June 7, 2017

Record last verified: 2017-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01166724
Data provider: ClinicalTrials.gov
Source updated: 2017-06-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:02 UTC

Locations

US(1)

Study Stopped

Renal Allograft Function and Histology Following Switching From A Tacrolimus to Sirolimus (SRL)-Based Immunosuppression-

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Sirolimus

Tacrolimus

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations