Kidney FailurePhase 4NCT00282217
Study Evaluating Sirolimus in the Treatment of Kidney Transplant
A Phase 4 study testing Sirolimus in people with Kidney Failure and Kidney Diseases, run by Wyeth is now a wholly owned subsidiary of Pfizer at 13 sites in Spain.
Trial summary
The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Failure, Kidney Diseases
- What is being tested?
- Sirolimus
- How many people
- 100 participants
- Where
- 13 sitesSpain
- Study dates
- Aug 2006to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Renal transplantation
- Biopsy-confirmed chronic rejection
- Treatment with mofetil mycophenolate among cyclosporine or tacrolimus
Who cannot join
- Transplant of any organ other than the kidney
- Current important infection
- Acute rejection within 12 weeks prior to inclusion
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Study site
A Coruña, 15006
Study site
Albacete, 2006
Study site
Barcelona, 8035
Study site
Cadiz, 11009
Study site
Granada, 18014
Study site
L'Hospitalet de Llobregat, 8701
Study site
Madrid, 28034
Study site
Madrid, 28035
Study site
Madrid, 28040
Study site
Málaga, 29010
Study site
Oviedo, 33006
Study site
Seville, 41013
Study site
Zaragoza, 50009
About this study
Official title: Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy
The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.
- Conditions
- Kidney Failure, Kidney Diseases
- Being tested
- Sirolimus
- Keywords
- Kidney Failure, Kidney Transplant, Graft Rejection, Kidney Transplantation
- Medical subject headings
- Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus
Secondary outcomes (3)
Histological parameters at 12 months
Cumulative incidence of biopsy-confirmed acute rejection at 12 months
Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startAug 2006
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 PfizerTrial Manager, Principal investigator, For Spain, infomed@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282217
- Sponsor's protocol ID
- 101467
- Status last verified
- Mar 2007
- First submitted
- 24 Jan 2006
- Last updated
- 22 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy
- ClinicalTrials.gov ID
- NCT00282217
- Acronym / sponsor ID
- 101467
- Conditions
- Kidney Failure, Kidney Diseases
- Keywords
- Kidney Failure, Kidney Transplant, Graft Rejection, Kidney Transplantation
- 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
- Aug 2006
- First posted
- 25 Jan 2006 (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 aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Renal transplantation
- Biopsy-confirmed chronic rejection
- Treatment with mofetil mycophenolate among cyclosporine or tacrolimus
Key exclusion criteria (3 listed)
- Transplant of any organ other than the kidney
- Current important infection
- Acute rejection within 12 weeks prior to inclusion
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 |
|---|---|---|
| Sirolimus | Drug | – |
Primary outcome
Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus
3 secondary outcomes
Histological parameters at 12 months
Cumulative incidence of biopsy-confirmed acute rejection at 12 months
Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria
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 22 Mar 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
Trial Manager principal investigator
For Spain, infomed@wyeth.com
13 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 Sirolimus in people with Kidney Failure and Kidney Diseases, run by Wyeth is now a wholly owned subsidiary of Pfizer at 13 sites in Spain.
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 22 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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?
Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus. 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 22 Mar 2007.