Graft RejectionPhase 4NCT00261820

Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

A Phase 4 study testing tacrolimus, mycophenolate mofetil and methylprednisolone in people with Graft Rejection and Kidney Failure, 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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Graft Rejection, Kidney Failure, Kidney Transplantation
What is being tested?: tacrolimus, mycophenolate mofetil and methylprednisolone
How many people: 160 participants
Where: No sites listed yet
Study dates: Start not givento Jan 2005
Phase: Phase 4
Are there results?: None posted in the registry

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: 18 and < 65 years
End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor
Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant

Who cannot join

Evidence of active systemic or localized major infection at the time of initial sirolimus administration
Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase

About this study

Official title: A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft Recipients:Sirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction (RATG) Vs Tacrolimus Plus Mycophenolate Mofetil Plus Corticosteroids

Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.

Conditions: Graft Rejection, Kidney Failure, Kidney Transplantation
Being tested: tacrolimus, mycophenolate mofetil, methylprednisolone, prednisolone, sirolimus
Keywords: Kidney Transplant
Medical subject headings: Renal Insufficiency

What participants receive

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

What is being measured

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

- Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-
transplantation.

Secondary outcomes (4)

Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff
criteria at 3, 6 and 12 Months following transplantation
One year graft biopsy status
Incidence of document infection

Timeline

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

?Jan 2005

First posted5 Dec 2005 (estimated)
Study completionJan 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Graft RejectionStudies 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: 160 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00261820
Sponsor's protocol ID: 0468E1-100194
Status last verified: May 2006
First submitted: 2 Dec 2005
Last updated: 19 May 2006
Results posted: No

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

RecruitingObservational study
Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
Graft-versus-leukemia, Graft vs Host Disease
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
Enrolling by invitationPhase 3
A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)
Antibody-mediated Rejection, Microvascular Inflammation
Not yet recruiting
Molecular Evidence of Rejection Intervention Trial
Heart Transplant Rejection

All Graft Rejection trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft Recipients:Sirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction (RATG) Vs Tacrolimus Plus Mycophenolate Mofetil Plus Corticosteroids
ClinicalTrials.gov ID: NCT00261820
Acronym / sponsor ID: 0468E1-100194
Conditions: Graft Rejection, Kidney Failure, Kidney Transplantation
Keywords: Kidney Transplant
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study completion: Jan 2005
First posted: 5 Dec 2005 (estimated)
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.

Study design

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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age: 18 and < 65 years
End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor
Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant

Key exclusion criteria (3 listed)

Evidence of active systemic or localized major infection at the time of initial sirolimus administration
Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase

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	–
mycophenolate mofetil	Drug	–
methylprednisolone	Drug	–
prednisolone	Drug	–
sirolimus	Drug	–

Primary outcome

- Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-
transplantation.

4 secondary outcomes

Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff
criteria at 3, 6 and 12 Months following transplantation
One year graft biopsy status
Incidence of document infection

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2006.

Related trials for Graft Rejection

RecruitingObservational study
Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
Graft-versus-leukemia, Graft vs Host Disease
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
Enrolling by invitationPhase 3
A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)
Antibody-mediated Rejection, Microvascular Inflammation
Not yet recruiting
Molecular Evidence of Rejection Intervention Trial
Heart Transplant Rejection

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 Belgium, trials-BEL@wyeth.com

Trial Manager principal investigator

For France, infomedfrance@wyeth.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tacrolimus, mycophenolate mofetil and methylprednisolone in people with Graft Rejection and Kidney Failure, 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 3 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 19 May 2006. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

- Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-. 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?

On the ClinicalTrials.gov record for NCT00261820.

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 19 May 2006.