Renal TransplantationNCT00240214
Study Evaluating Rapamune in Patients After Kidney Transplantation
An observational study of Renal Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Germany.
Trial summary
The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- sirolimus
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2001to Feb 2008
- Phase
- Observational
- 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
Study population: primary care clinic
Who may be able to join
- Patients having received a renal allograft from a cadaveric or living donor with low or moderate risk of developing acute rejection episodes.
Who cannot join
- Contraindications according to Summary of the Product Characteristics (SmPC).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Post Marketing Surveillance Assessment to Evaluate the Effectiveness and Safety of Rapamune in Patients After Kidney Transplantation Receiving a Rapamune Containing Regime
The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions
- Conditions
- Renal Transplantation
- Being tested
- sirolimus
- Keywords
- Kidney transplants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimusDrug
Tablet, dosage is determined by trough level
| Study group | Role | What they receive |
|---|---|---|
| 1 | sirolimus Receives: Drug: sirolimus |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startApr 2001
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 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, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Germany, medinfoDEU@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240214
- Sponsor's protocol ID
- 0468E-100875
- Status last verified
- Mar 2008
- First submitted
- 13 Oct 2005
- Last updated
- 14 Mar 2008
- Results posted
- 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
- An Open Label Post Marketing Surveillance Assessment to Evaluate the Effectiveness and Safety of Rapamune in Patients After Kidney Transplantation Receiving a Rapamune Containing Regime
- ClinicalTrials.gov ID
- NCT00240214
- Acronym / sponsor ID
- 0468E-100875
- Conditions
- Renal Transplantation
- Keywords
- Kidney transplants
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 17 Oct 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.
The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: sirolimussirolimus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Patients having received a renal allograft from a cadaveric or living donor with low or moderate risk of developing acute rejection episodes.
Key exclusion criteria (1 listed)
- Contraindications according to Summary of the Product Characteristics (SmPC).
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 |
|---|---|---|
| sirolimusTablet, dosage is determined by trough level | Drug | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2008.
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Evaluation of the Efficacy of Dd-cfDNA in Routine Patient Care in Kidney Transplant Recipients"
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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 Germany, medinfoDEU@wyeth.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Germany.
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 1 inclusion and 1 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: stopped early, 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 1 site in Germany. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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 14 Mar 2008; AzTrials last refreshed its copy on 3 Nov 2026.