Kidney TransplantationNCT00780429
Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients
An observational study of Kidney Transplantation, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Study of the pharmacokinetic and pharmacodynamic variability of mycophenolate mofetil in renal transplant patients already on long-term MMF treatment (at least 6 months post-transplant; at least 3 months in therapy). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplantation
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2006to not given
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female renal transplant patients
Who may be able to join
- Renal transplant recipients
- Age range: 18-70
- Patients taking MMF
- Able to understand and sign an informed consent
Who cannot join
- Active myelodepression
- Systemic infections or other that may affect MMF absorption
- Pregnancy/breastfeeding
- (History of) cancer
- Drug abuse, psychiatric conditions
- Already enrolled in other clinical trials or participation ended less than one month earlier
- Known sensitivity to polysorbate 80 or MMF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pharmacokinetic and Pharmacodynamic Parameters in Renal Transplant Patients Receiving Mycophenolic Acid and Stable for at Least 3 Months
Study of the pharmacokinetic and pharmacodynamic variability of mycophenolate mofetil in renal transplant patients already on long-term MMF treatment (at least 6 months post-transplant; at least 3 months in therapy).
Study hypothesis: to investigate whether long-term MMF therapy alters IMPDH biological activity and if there are any correlations with the risk of AR.
- Conditions
- Kidney Transplantation
- Keywords
- kidney, transplant, Mycophenolic acid, Inosine monophosphate dehydrogenase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | MMF+cyclosporine | |
| 2 | MMF+tacrolimus | |
| 3 | MMF+sirolimus |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780429
- Sponsor's protocol ID
- 06/2006/REVO
- Status last verified
- Oct 2008
- First submitted
- 24 Oct 2008
- Last updated
- 27 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacokinetic and Pharmacodynamic Parameters in Renal Transplant Patients Receiving Mycophenolic Acid and Stable for at Least 3 Months
- ClinicalTrials.gov ID
- NCT00780429
- Acronym / sponsor ID
- 06/2006/REVO
- Conditions
- Kidney Transplantation
- Keywords
- kidney, transplant, Mycophenolic acid, Inosine monophosphate dehydrogenase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jun 2006
- First posted
- 27 Oct 2008 (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.
Study of the pharmacokinetic and pharmacodynamic variability of mycophenolate mofetil in renal transplant patients already on long-term MMF treatment (at least 6 months post-transplant; at least 3 months in therapy).
Study hypothesis: to investigate whether long-term MMF therapy alters IMPDH biological activity and if there are any correlations with the risk of AR.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –MMF+cyclosporine |
| 2 | – | –MMF+tacrolimus |
| 3 | – | –MMF+sirolimus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female renal transplant patients
Key inclusion criteria (4 listed)
- Renal transplant recipients
- Age range: 18-70
- Patients taking MMF
- Able to understand and sign an informed consent
Key exclusion criteria (7 listed)
- Active myelodepression
- Systemic infections or other that may affect MMF absorption
- Pregnancy/breastfeeding
- (History of) cancer
- Drug abuse, psychiatric conditions
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 27 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Kidney Transplantation, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site 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: status not confirmed, as of the sponsor's last update on 27 Oct 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 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.
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 27 Oct 2008.