Kidney FailurePhase 4NCT00195429

A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

A Phase 4 study testing Tacrolimus, Sirolimus and prednisone in people with Kidney Failure and Graft vs Host Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Brazil.

Completed

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

Official record

Search all trials

Trial summary

This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone. Read more about this study

Who is it for?: Ages 13 years and older
Conditions the study is for: Kidney Failure, Graft vs Host Disease
What is being tested?: Tacrolimus, Sirolimus and prednisone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteBrazil
Study dates: Aug 2005to Oct 2007
Phase: Phase 4
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

End-stage renal disease, with patients scheduled to receive a kidney transplant.
Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
Signed informed consent.

Who cannot join

Evidence of active systemic or localized major infection at the time of initial study drug administration;
Multiple organ transplants;
Any pathology or medical condition that can interfere with this protocol study proposal.
Other exclusion applies.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Study site
São Paulo

Other trials in Brazil

About this study

Official title: A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients

Conditions: Kidney Failure, Graft vs Host Disease
Being tested: Tacrolimus, Sirolimus, prednisone
Keywords: Kidney, Transplant
Medical subject headings: Renal Insufficiency, Graft vs Host Disease

What participants receive

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

Study groups in NCT00195429
Study group	Role	What they receive
Sirolimus + Tacrolimus	Experimental	Not described Receives: Drug: Tacrolimus; Drug: Sirolimus
Sirolimus + Prednisone	Active comparator	Not described Receives: Drug: Sirolimus; Drug: prednisone

What is being measured

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

Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).
Measured: 12 months

Secondary outcomes (1)

Creatinine Clearance Rate
Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Measured: 12 months

Timeline

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

Aug 2005Oct 2007

First posted19 Sep 2005 (estimated)
Study startAug 2005
Study completionOct 2007

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.
Other trials for Kidney FailureStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00195429
Sponsor's protocol ID: 0468E-101535
Status last verified: Apr 2010
First submitted: 12 Sep 2005
Last updated: 11 Dec 2023
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Kidney Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients
ClinicalTrials.gov ID: NCT00195429
Acronym / sponsor ID: 0468E-101535
Conditions: Kidney Failure, Graft vs Host Disease
Keywords: Kidney, Transplant
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2005
Study completion: Oct 2007 (actual)
First posted: 19 Sep 2005 (estimated)
Results: Posted 2 Jun 2009

Clinical summary

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

Study design

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

Arm	Type	Receives
Sirolimus + Tacrolimus	Experimental	Drug: Tacrolimus, Drug: Sirolimus
Sirolimus + Prednisone	Active comparator	Drug: Sirolimus, Drug: prednisone

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)

End-stage renal disease, with patients scheduled to receive a kidney transplant.
Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
Signed informed consent.

Key exclusion criteria (4 listed)

Evidence of active systemic or localized major infection at the time of initial study drug administration;
Multiple organ transplants;
Any pathology or medical condition that can interfere with this protocol study proposal.
Other exclusion applies.

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
Tacrolimus	Drug	Sirolimus + Tacrolimus
Sirolimus	Drug	Sirolimus + Prednisone, Sirolimus + Tacrolimus
prednisone	Drug	Sirolimus + Prednisone

Primary outcome

Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
Time frame: 12 months
Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).

1 secondary outcome

Creatinine Clearance Rate
Time frame: 12 months

Results and safety

Results posted to the registry on 2 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sirolimus + Tacrolimus	24	19
Sirolimus + Prednisone	23	18

Primary outcome: Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.

Time frame: 12 months. Number. Unit: participants

Measure	Sirolimus + Tacrolimus n = 24	Sirolimus + Prednisone n = 23
Subjects with Acute Rejection	3	3
Subjects without Acute Rejection	21	20

Sirolimus + Tacrolimus vs Sirolimus + Prednisone: p = 1.0, Fisher Exact

Population analysed: The population that was used for this analysis was the transplantation recipient population, which included all randomized patients.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sirolimus + Tacrolimus	0 of 24 (0%)	23 of 24 (95.8%)	Not reported
Sirolimus + Prednisone	0 of 23 (0%)	22 of 23 (95.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Kidney Failure

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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 study director

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager principal investigator

For Brazil, xavierl@wyeth.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tacrolimus, Sirolimus and prednisone in people with Kidney Failure and Graft vs Host Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Brazil.

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 4 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 11 Dec 2023. 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 Brazil. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 2 Jun 2009). 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?

Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up. (time frame: 12 months). 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 NCT00195429.

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 11 Dec 2023.