Chronic Kidney FailurePhase 4NCT00044720
Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients
A Phase 4 study testing Rapamune in people with Chronic Kidney Failure and Graft vs Host Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The incidence of efficacy failure at 12 months between two regimens. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Chronic Kidney Failure, Graft vs Host Disease, Kidney Transplantation
- What is being tested?
- Rapamune
- How many people
- 484 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jul 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 13 years or older, 40 kgs or more
- End-stage renal disease
- African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft
Who cannot join
- Evidence of active infection
- Evidence abnormal chest x-ray
- Patients with HIV.
About this study
Official title: An Open-label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor
The incidence of efficacy failure at 12 months between two regimens.
- Being tested
- Rapamune
- Keywords
- Kidney Transplant
- Medical subject headings
- Kidney Failure, Chronic, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamuneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2002 (estimated)
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, MD, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044720
- Sponsor's protocol ID
- 0468H1-101164
- Status last verified
- Aug 2009
- First submitted
- 4 Sep 2002
- Last updated
- 18 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor
- ClinicalTrials.gov ID
- NCT00044720
- Acronym / sponsor ID
- 0468H1-101164
- Keywords
- Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 6 Sep 2002 (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.
The incidence of efficacy failure at 12 months between two regimens.
Study design
- Allocation
- Randomised
- Masking
- None (open label)
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: 13 years or older, 40 kgs or more
- End-stage renal disease
- African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft
Key exclusion criteria (3 listed)
- Evidence of active infection
- Evidence abnormal chest x-ray
- Patients with HIV.
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 |
|---|---|---|
| Rapamune | Drug | – |
Primary outcome
Not reported in the source record.
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 18 Aug 2009.
Related trials for Chronic 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
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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 4 study testing Rapamune in people with Chronic Kidney Failure and Graft vs Host Disease, 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 18 Aug 2009. 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.
Where can I read the original study information?
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 18 Aug 2009.