TransplantationNCT00195195
Study Evaluating Rapamune in Transplant Recipients in the Nordic Countries
An observational study of Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in Sweden.
Trial summary
The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transplantation
- What is being tested?
- Sirolimus
- How many people
- 66 participants
- Where
- 3 sitesSweden
- Study dates
- Jan 2005to Jun 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: Transplantation patients treated with sirolimus.
Who may be able to join
- Transplantation patients treated with sirolimus (Rapamune).
Who cannot join
- Patients must be able to give informed consent.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Study site
Gothenburg, SE-413 45
Study site
Stockholm, SE-141 86
Study site
Uppsala, SE-751 85
About this study
Official title: A Rapamune Follow-up Registry in Transplant Recipients in the Nordic Countries, "Wrap-up"
The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients.
- Conditions
- Transplantation
- Being tested
- Sirolimus
- Keywords
- Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamune
Transplantation patients treated with sirolimus who consent to participate in the study (register)
| 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 posted19 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195195
- Sponsor's protocol ID
- 0468-101157
- Status last verified
- Jan 2012
- First submitted
- 12 Sep 2005
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rapamune Follow-up Registry in Transplant Recipients in the Nordic Countries, "Wrap-up"
- ClinicalTrials.gov ID
- NCT00195195
- Acronym / sponsor ID
- 0468-101157
- Conditions
- Transplantation
- Keywords
- Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (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.
The purpose of this study is to gather information about the long-term effects and safety of treatment with Rapamune in transplant patients.
Study design
- Observational model
- Case only
- 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
- Transplantation patients treated with sirolimus.
Key inclusion criteria (1 listed)
- Transplantation patients treated with sirolimus (Rapamune).
Key exclusion criteria (1 listed)
- Patients must be able to give informed consent.
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 |
|---|---|---|
| SirolimusAlso: RapamuneTransplantation patients treated with sirolimus who consent to participate in the study (register) | Drug | 1 |
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 31 Jan 2012.
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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.
Pfizer CT.gov Call Center study director
Wyeth is now a wholly owned subsidiary of Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in Sweden.
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: finished, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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 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 31 Jan 2012.