Renal TransplantationPhase 4NOCTX-2NCT01276834
Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation
A Phase 4 study testing everolimus in people with Renal Transplantation, run by Dianet Dialysis Centers at 1 site in Netherlands.
Trial summary
To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2010to Jul 2012
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-75 yr
- Willingness to provide written informed consent
- Ability to understand the study procedures
Who cannot join
- Life expectancy < 3 months
- Claustrophobia
- Allergy to iodinated contrast
- Treatment incompliance
- Pregnancy
- Highly HLA-sensitized patients
Show all 9Show fewer
- Severe dyslipidemia or proteinuria
- Severe leucopenia or thrombocytopenia
- GFR < 30 ml/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.
To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after transplantation.
- Conditions
- Renal Transplantation
- Being tested
- everolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
comparison of everolimus-based and CNI-based immunosuppression
| Study group | Role | What they receive |
|---|---|---|
| everolimus-based immunosuppression | Experimental | immunosuppression with everolimus, prednisone and mycophenolate Receives: Drug: everolimus |
| standard immunosuppression | Active comparator | immunosuppression with tacrolimus, prednisone and mycophenolate Receives: Drug: everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in coronary artery calcification score
Comparison in a randomised way the effect of a calcineurin-based immunosuppressive regimen with an mTOR-based regimen on progression of coronary calcification on renal transplant patients.
The results of this study will provide more insight in protection against cardiovascular disease in renal transplant patients.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: insufficient patients enrolled
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dianet Dialysis Centers
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Responsible party
- Principal investigator, B.C. van Jaarsveld, MD PhD, Dianet Dialysis Centers
- Investigators
- Franka E van Reekum, MD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276834
- Sponsor's protocol ID
- NOCTX-2
- Other IDs
- 2009-011605-16, 2009
- Acronym
- NOCTX-2
- Status last verified
- Aug 2017
- First submitted
- 12 Jan 2011
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.
- ClinicalTrials.gov ID
- NCT01276834
- Acronym / sponsor ID
- NOCTX-2 / NOCTX-2
- Conditions
- Renal Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient patients enrolled
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Dianet Dialysis CentersUniversity, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- Sep 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Jan 2011 (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.
To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| everolimus-based immunosuppression | Experimental | Drug: everolimusimmunosuppression with everolimus, prednisone and mycophenolate |
| standard immunosuppression | Active comparator | Drug: everolimusimmunosuppression with tacrolimus, prednisone and mycophenolate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18-75 yr
- Willingness to provide written informed consent
- Ability to understand the study procedures
Key exclusion criteria (9 listed)
- Life expectancy < 3 months
- Claustrophobia
- Allergy to iodinated contrast
- Treatment incompliance
- Pregnancy
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 |
|---|---|---|
| everolimuscomparison of everolimus-based and CNI-based immunosuppression | Drug | everolimus-based immunosuppression, standard immunosuppression |
Primary outcome
change in coronary artery calcification score
Time frame: 3 years
Comparison in a randomised way the effect of a calcineurin-based immunosuppressive regimen with an mTOR-based regimen on progression of coronary calcification on renal transplant patients. The results of this study will provide more insight in protection against cardiovascular disease in renal transplant patients.
Results and safety
The study was stopped early (reason given: insufficient patients enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
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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.
Franka E van Reekum, MD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing everolimus in people with Renal Transplantation, run by Dianet Dialysis Centers at 1 site in Netherlands.
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 9 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 7 Aug 2017. 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 Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: insufficient patients enrolled). 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.
What does the primary outcome measure?
change in coronary artery calcification score (time frame: 3 years). 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 7 Aug 2017.