Kidney FailurePhase 4NCT00195481
Study Evaluating Sirolimus in Kidney Transplant Recipients in India
A Phase 4 study testing Rapamune in people with Kidney Failure and Graft vs Host Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 5 sites in India.
Trial summary
To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting. 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?
- Rapamune
- How many people
- 100 participants
- Where
- 5 sitesIndia
- Study dates
- Apr 2004to Dec 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
- Patients in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms.
- Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor.
Who cannot join
- Evidence of major infections at the time of sirolimus administration
- Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the treatment phase.
- Females who are pregnant, breast feeding or in reproductive age group and not using a medically acceptable form of contraception
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Study site
Bangalore, Karnataka, 566 006
Study site
Bangalore, Karnataka, 566 018
Study site
Chennai, Tamil Nadu, 600 004
Study site
New Delhi
Study site
Sāket, South Delhi
About this study
Official title: A Post Marketing Surveillance Looking at Safety of Rapamune (Sirolimus) in Indian Population Undergoing de Novo Renal Transplantation.
To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.
- Conditions
- Kidney Failure, Graft vs Host Disease
- Being tested
- Rapamune
- 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.
RapamuneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195481
- Sponsor's protocol ID
- 0468H-101543
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Surveillance Looking at Safety of Rapamune (Sirolimus) in Indian Population Undergoing de Novo Renal Transplantation.
- ClinicalTrials.gov ID
- NCT00195481
- Acronym / sponsor ID
- 0468H-101543
- Conditions
- Kidney Failure, Graft vs Host Disease
- Keywords
- Kidney, Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 19 Sep 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.
To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (2 listed)
- Patients in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms.
- Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor.
Key exclusion criteria (3 listed)
- Evidence of major infections at the time of sirolimus administration
- Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the treatment phase.
- Females who are pregnant, breast feeding or in reproductive age group and not using a medically acceptable form of contraception
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
Safety evaluation
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 28 Dec 2007.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rapamune in people with Kidney Failure and Graft vs Host Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 5 sites in India.
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 2 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 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. 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?
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?
Safety evaluation. It is what the study was designed to measure, not a finding.
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 28 Dec 2007.