Renal TransplantationPhase 3NCT00038948

Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

A Phase 3 study testing Sirolimus, tacrolimus and Cyclosporine A in people with Renal Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function. Read more about this study

Who is it for?: Ages 13 years and older
Conditions the study is for: Renal Transplantation
What is being tested?: Sirolimus, tacrolimus and Cyclosporine A
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 830 participants
Where: No sites listed yet
Study dates: Jan 2002to May 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 13 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Age greater than or equal to 13 years.
Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Who cannot join

Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
Patients in whom kidney-pancreas or other multiple organ transplants have been performed

About this study

Official title: A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

Conditions: Renal Transplantation
Being tested: Sirolimus, tacrolimus, Cyclosporine A
Keywords: Renal, Allograft, Recipients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SirolimusDrug
Sirolimus, Cyclosporine A \& Tacrolimus are concentration controlled
tacrolimusDrug
Cyclosporine ADrug

Study groups in NCT00038948
Study group	Role	What they receive
A	Active comparator	Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression Receives: Drug: Sirolimus; Drug: tacrolimus; Drug: Cyclosporine A
B	Active comparator	Continued calcineurin inhibitor therapy Receives: Drug: Sirolimus; Drug: tacrolimus; Drug: Cyclosporine A

What is being measured

The primary outcome is the main question the study is designed to answer.

Nankivell Glomerular Filtration Rate (GFR)
Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.
Measured: 52 weeks

Secondary outcomes (1)

First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).
Measured: 52 and 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2002May 2008

First posted7 Jun 2002 (estimated)
Study startJan 2002
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal TransplantationStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 830 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00038948
Sponsor's protocol ID: 0468H1-316
Status last verified: Apr 2010
First submitted: 5 Jun 2002
Last updated: 14 May 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Reichen J, Stickel F, Bhattacharya I, Matschke K, Maller E, Korth-Bradley J. Repeat-dose sirolimus pharmacokinetics and pharmacodynamics in patients with hepatic allografts. Eur J Clin Pharmacol. 2012 May;68(5):589-97. doi: 10.1007/s00228-011-1172-7. Epub 2011 Dec 6.
PubMed 22143911

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
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CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
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Evaluation of the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"
Renal Transplantation
Not yet recruitingPhase 3
To Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation

All Renal Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients
ClinicalTrials.gov ID: NCT00038948
Acronym / sponsor ID: 0468H1-316
Conditions: Renal Transplantation
Keywords: Renal, Allograft, Recipients
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 830 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2002
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 7 Jun 2002 (estimated)
Results: Posted 14 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: Sirolimus, Drug: tacrolimus, Drug: Cyclosporine AConversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
B	Active comparator	Drug: Sirolimus, Drug: tacrolimus, Drug: Cyclosporine AContinued calcineurin inhibitor therapy

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Age greater than or equal to 13 years.
Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Key exclusion criteria (2 listed)

Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
Patients in whom kidney-pancreas or other multiple organ transplants have been performed

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
SirolimusSirolimus, Cyclosporine A \& Tacrolimus are concentration controlled	Drug	A, B
tacrolimus	Drug	A, B
Cyclosporine A	Drug	A, B

Primary outcome

Nankivell Glomerular Filtration Rate (GFR)
Time frame: 52 weeks
Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.

1 secondary outcome

First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
Time frame: 52 and 104 weeks

Results and safety

Results posted to the registry on 14 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SRL Conversion in Stable Renal Transplant Recipients	555	386
CNI Continuation in Stable Renal Transplant Recipients	275	198

Primary outcome: Nankivell Glomerular Filtration Rate (GFR)

Time frame: 52 weeks. Mean (Standard Error). Unit: mL/min

Measure	SRL Conversion Strata 20.0-40.0 mL/Min n = 58	CNI Continuation Strata 20.0-40.0 mL/Min n = 29	SRL Conversion Strata >40.0 mL/Min n = 496	CNI Continuation Strata >40.0 mL/Min n = 245
Value	24.56 (2.42)	27.24 (3.71)	59.04 (0.89)	57.73 (1.1)

SRL Conversion Strata 20.0-40.0 mL/Min vs CNI Continuation Strata 20.0-40.0 mL/Min: Weighted difference: -2.68 (95% CI -12.27 to 6.91), p = 0.575, ANCOVA
SRL Conversion Strata >40.0 mL/Min vs CNI Continuation Strata >40.0 mL/Min: Weighted difference: 1.31 (95% CI -1.06 to 3.69), p = 0.278, ANCOVA

Population analysed: Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR \>40 mL/min.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SRL Conversion in Stable Renal Transplant Recipients	81 of 551 (14.7%)	545 of 551 (98.9%)	Not reported
CNI Continuation in Stable Renal Transplant Recipients	45 of 273 (16.5%)	264 of 273 (96.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22143911Reichen J, Stickel F, Bhattacharya I, Matschke K, Maller E, Korth-Bradley J. Repeat-dose sirolimus pharmacokinetics and pharmacodynamics in patients with hepatic allografts. Eur J Clin Pharmacol. 2012 May;68(5):589-97. doi: 10.1007/s00228-011-1172-7. Epub 2011 Dec 6.

Related trials for Renal Transplantation

Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
RecruitingPhase 2/3
CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
Kidney Pancreas Transplantation
Active, not recruiting
Evaluation of the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"
Renal Transplantation
Not yet recruitingPhase 3
To Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation

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. This study is not recruiting at the moment.

Medical Monitor, MD study director

Wyeth is now a wholly owned subsidiary of Pfizer

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sirolimus, tacrolimus and Cyclosporine A in people with Renal Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 14 May 2010. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nankivell Glomerular Filtration Rate (GFR) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00038948, which also lists 1 linked publication.

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 14 May 2010; AzTrials last refreshed its copy on 3 Nov 2026.