Kidney Function After TransplantationESPNCT00461357
Sirolimus Based Immunosuppression for Patients Undergoing Kidney Transplantation in the Eurotransplant Senior Program
An observational study of Kidney Function After Transplantation and Outcome After Kidney Transplantation, run by Medical University of Vienna.
Trial summary
The Eurotransplant Senior Program (ESP) started in 1999 with local allocation of kidneys from deceased donors elder than 65 years to recipients elder than 65 years. The requirements for immunosuppression in this group of patients are high due to the large amount of comorbidities. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Kidney Function After Transplantation, Outcome After Kidney Transplantation
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Dec 2007
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Recipients of the Eurotransplant Senior Program
- negative cytotoxic crossmatch
- signed informed consent
Who cannot join
- High sensitized recipients (PRA > 40%)
- Non heart Beating Donor
- Hyperlipidemia
- Leucocytopenia (< 3000/mm3)
- Thrombocytopenia (< 75000/mm3)
About this study
Official title: Outcome After Renal Transplantation of a Randomized Prospective Trial in the Eurotransplant Senior Program
The Eurotransplant Senior Program (ESP) started in 1999 with local allocation of kidneys from deceased donors elder than 65 years to recipients elder than 65 years. The requirements for immunosuppression in this group of patients are high due to the large amount of comorbidities.
This prospective randomized trial compared the standard immunosuppressive protocol based on cyclosporine A (CyA) used at our center within the ESP, to a calcineurin inhibitor-free protocol based on sirolimus (SRL).
The aim of this study is to investigate the effect of a CNI-free therapy on the function of elderly kidneys 6 months post transplantation, measured by GFR.
- Keywords
- Old for Old, Eurotransplant Senior Program, Glomerular Filtration Rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startJan 2003
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Function After TransplantationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Ferdinand Muehlbacher, MD Professor, Principal investigator, Medical University of Vienna; Department of Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461357
- Sponsor's protocol ID
- NTX-OFO-01
- Acronym
- ESP
- Status last verified
- Apr 2007
- First submitted
- 17 Apr 2007
- Last updated
- 18 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Renal Transplantation of a Randomized Prospective Trial in the Eurotransplant Senior Program
- ClinicalTrials.gov ID
- NCT00461357
- Acronym / sponsor ID
- ESP / NTX-OFO-01
- Keywords
- Old for Old, Eurotransplant Senior Program, Glomerular Filtration Rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Dec 2007 (estimated)
- First posted
- 18 Apr 2007 (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 Eurotransplant Senior Program (ESP) started in 1999 with local allocation of kidneys from deceased donors elder than 65 years to recipients elder than 65 years. The requirements for immunosuppression in this group of patients are high due to the large amount of comorbidities.
This prospective randomized trial compared the standard immunosuppressive protocol based on cyclosporine A (CyA) used at our center within the ESP, to a calcineurin inhibitor-free protocol based on sirolimus (SRL).
The aim of this study is to investigate the effect of a CNI-free therapy on the function of elderly kidneys 6 months post transplantation, measured by GFR.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Recipients of the Eurotransplant Senior Program
- negative cytotoxic crossmatch
- signed informed consent
Key exclusion criteria (5 listed)
- High sensitized recipients (PRA > 40%)
- Non heart Beating Donor
- Hyperlipidemia
- Leucocytopenia (< 3000/mm3)
- Thrombocytopenia (< 75000/mm3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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.
Ferdinand Muehlbacher, MD Professor principal investigator
Medical University of Vienna; Department of Transplantation
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Function After Transplantation and Outcome After Kidney Transplantation, run by Medical University of Vienna.
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 5 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: status not confirmed, as of the sponsor's last update on 18 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
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 18 Apr 2007.