Kidney FailurePhase 3NCT00167947
Study Evaluating Sirolimus in Kidney Transplant Recipients.
A Phase 3 study testing Cyclosporine, Steroids and Rapamune (Sirolimus) in people with Kidney Failure and Graft vs Host Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 14 sites in Italy.
Trial summary
Renal function at 12 months assessed by calculated creatinine clearance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Graft vs Host Disease
- What is being tested?
- Cyclosporine, Steroids and Rapamune (Sirolimus)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 14 sitesItaly
- Study dates
- Jan 2005to Jul 2007
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is older than 18 years.
- End-stage renal disease, with subjects scheduled for kidney transplant.
- Women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.
- Other inclusion applies.
Who cannot join
- Evidence of active systemic or localized major infection.
- Use of any investigational drug or treatment up to 4 weeks prior to study entry.
- Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, basiliximab.
- Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).
- Immunosuppression therapies other than those allowed in the protocol.
- Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (all known to interact with SRL) that is not discontinued prior to study entry.
- Other exclusion applies.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
Study site
Bari, 70100
Study site
Bologna, 40138
Study site
Cagliari, 09125
Study site
Florence, 50139
Study site
L’Aquila, 67100
Study site
Milan, 20162
Study site
Palermo, Sicily, 90127
Study site
Pisa, 56100
Study site
Rome, Lazio, 00144
Study site
Rome, Lazio, 00168
Study site
Sassari, 07100
Study site
Siena, 53100
Study site
Udine, 37100
Study site
Varese, 21100
About this study
Official title: A Randomized, Open Label Study to Evaluate the Effects of a Regimen With Sirolimus,Low Doses Cyclosporine and Steroids vs a Regimen With Sirolimus and Steroids, After an Induction Period With Basiliximab, Sirolimus,Cyclosporine and Steroids in de Novo Renal Transplant Patients.
Renal function at 12 months assessed by calculated creatinine clearance.
- Conditions
- Kidney Failure, Graft vs Host Disease
- Being tested
- Cyclosporine, Steroids, Rapamune (Sirolimus)
- 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.
CyclosporineDrug
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
SteroidsDrug
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Rapamune (Sirolimus)Drug
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Cyclosporine; Drug: Steroids; Drug: Rapamune (Sirolimus) |
| B | Experimental | Not described Receives: Drug: Cyclosporine; Drug: Steroids; Drug: Rapamune (Sirolimus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2007
- Study completionJul 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
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 Italy, decresg@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167947
- Sponsor's protocol ID
- 0468E-101629
- Status last verified
- Mar 2008
- First submitted
- 9 Sep 2005
- Last updated
- 14 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Study to Evaluate the Effects of a Regimen With Sirolimus,Low Doses Cyclosporine and Steroids vs a Regimen With Sirolimus and Steroids, After an Induction Period With Basiliximab, Sirolimus,Cyclosporine and Steroids in de Novo Renal Transplant Patients.
- ClinicalTrials.gov ID
- NCT00167947
- Acronym / sponsor ID
- 0468E-101629
- Conditions
- Kidney Failure, Graft vs Host Disease
- Keywords
- Kidney, Transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 14 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.
Renal function at 12 months assessed by calculated creatinine clearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Cyclosporine, Drug: Steroids, Drug: Rapamune (Sirolimus) |
| B | Experimental | Drug: Cyclosporine, Drug: Steroids, Drug: Rapamune (Sirolimus) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age is older than 18 years.
- End-stage renal disease, with subjects scheduled for kidney transplant.
- Women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.
- Other inclusion applies.
Key exclusion criteria (7 listed)
- Evidence of active systemic or localized major infection.
- Use of any investigational drug or treatment up to 4 weeks prior to study entry.
- Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, basiliximab.
- Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).
- Immunosuppression therapies other than those allowed in the protocol.
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 |
|---|---|---|
| CyclosporineArm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " | Drug | A, B |
| SteroidsArm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " | Drug | A, B |
| Rapamune (Sirolimus)Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " | Drug | A, B |
Primary outcome
To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids.
Time frame: 6 months
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 14 Mar 2008.
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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 Italy, decresg@wyeth.com
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclosporine, Steroids and Rapamune (Sirolimus) in people with Kidney Failure and Graft vs Host Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 14 sites in Italy.
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 4 inclusion and 7 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 14 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids. (time frame: 6 months). 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 14 Mar 2008.