Renal TransplantationPhase 4NCT00148252
Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant
A Phase 4 study testing Mycophenolate mofetil withdrawal and Cyclosporione A withdrawal in people with Renal Transplantation, run by University of Oslo School of Pharmacy at 9 sites in Norway.
Trial summary
To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Mycophenolate mofetil withdrawal and Cyclosporione A withdrawal
- How many people
- 298 participants
- Where
- 9 sitesNorway
- Study dates
- Feb 2003to Feb 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients of either gender above 18 years of age at time of randomisation. 2. More than twelve months posttransplant. 3. Treated with an immunosuppressive protocol consisting of CsA, MMF and steroid from the time of discharge from the transplant clinic (e.g. 3 months posttransplant).
- 4. Kidney (only) transplant recipients with stable renal function (S-creatinine < 300 umol/L and an average increase in S-creatinine < 20% the last 6 months prior to inclusion) and without treated clinically and/or biopsy proven acute rejection episodes the last 6 months prior to inclusion.
- 5. No previous steroid resistant acute rejections (e.g. treated with ATG/OKT3). 6. Not more than two steroid sensitive acute rejections posttransplant. 7. Signed informed consent.
Who cannot join
- 1. PRA positivity > 20%. 2. Concomitant therapy with other investigational drugs or prohibited medication specified in the protocol.
- 3. Life expectancy less than one year. 4. Acute illness or acute fungal, bacterial or viral infection at screening. 5. Unable and/or unlikely to follow the study protocol.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Norway9 sites
Haukeland sykehus
Bergen, 5021
Lillehammer hospital
Lillehammer, 2609
Akershus Hospital
Nordbyhagen, 1474
Rikshospitalet, Section of Nephrology
Oslo, Oslo, 0027
Ullevål hospital
Oslo, 0450
Hospital Telemark
Skien, 3710
Sentralsykehuset i Rogaland
Stavanger, 4068
Tromsø hospital
Tromsø, 9038
St. Olavs hospital
Trondheim, 7030
About this study
Official title: Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant - Randomised Withdrawal of Mycophenolate Mofetil (CellCept®) or Cyclosporine A (Sandimmun Neoral®)
To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy
Read the detailed description
To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy.
Secondly to examine safety following withdrawal of CsA or MMF, respectively, by the following parameters:
- Biopsy verified acute rejection episodes, time to first rejection and number of steroid resistant rejection episodes within 12 months.
- Hematology (Hb, WBC, platelets) abnormalities within 12 months.
- Graft and patient survival at 12 months and 5 years. Absolute difference in renal function between withdrawal groups at 12 months. Three monthly changes in renal function from drug withdrawal to 12 months. Change in dyslipidemia frequency from drug withdrawal to 12 months. Change in hypertension frequency from drug withdrawal to 12 months. Change in glucose tolerance from drug withdrawal to 12 months. Cumulative incidence of clinical infections resulting in hospitalization within 12 months.
Sub protocols will also examine the following aspects:
Cardiovascular: Homocysteine. Lipid peroxidation. Microvascular function and vasoactive parameters Quality of life (QoL): ESRD SCL-TM, SF-36 (short version) and EQ-5D (GI-checklist extended) questionnaires will be used.
Pharmacoeconomical evaluation.
- Conditions
- Renal Transplantation
- Being tested
- Mycophenolate mofetil withdrawal, Cyclosporione A withdrawal
- Keywords
- Calcineurin, reduction, immunosuppression, cyclosporine A, mycophenolate mofetil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate mofetil withdrawalDrug
Cyclosporione A withdrawalDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the absolute change in renal function from inclusion to 12 months post drug withdrawal, evaluated as GFR estimated from Nankivell's formula B and normalised for 1.73 m2 body-surface.
Secondary outcomes (10)
Graft and patient survival at 12 months and 5 years posttransplant.
Proportion of patients with biopsy-proven acute rejection or acute rejection (biopsy proven + presumptive) episodes within 12 months.
Incidence of HB, WBC, platelet abnormal values requiring clinical intervention within 12 months.
Incidence of need for additional immunosuppressive therapy at 12 months.
Absolute difference in renal function between treatment groups at 12 months, evaluated by Nankivell's formula (B).
Renal function (Nankivell's formula B) development over time (3 monthly) between treatment groups within 12 months.
Change in dyslipidemia frequency from drug withdrawal to 12 months.
Change in hypertension frequency from drug withdrawal to 12 months.
Change in glucose tolerance from drug withdrawal to 12 months.
Cumulative incidence of clinical infections resulting in hospitalization within 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionNov 2005
- Study completionFeb 2007
Why it stopped: To high rejection rate in CsA withdrawal arm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 298 participants
Sponsor and investigators
- Lead sponsor
- University of Oslo School of Pharmacy
- Sponsor type
- University, hospital or other
- Investigators
- Anders Åsberg, MSc, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148252
- Sponsor's protocol ID
- NILS 02-08144
- Status last verified
- Jun 2012
- First submitted
- 6 Sep 2005
- Last updated
- 7 Jun 2012
- Results posted
- No
Publications
Asberg A, Apeland T, Reisaeter AV, Foss A, Leivestad T, Heldal K, Thorud LO, Eriksen BO, Hartmann A; NILS Study Group. Long-term outcomes after cyclosporine or mycophenolate withdrawal in kidney transplantation - results from an aborted trial. Clin Transplant. 2013 Mar-Apr;27(2):E151-6. doi: 10.1111/ctr.12076. Epub 2013 Jan 27.
PubMed 23351013
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant - Randomised Withdrawal of Mycophenolate Mofetil (CellCept®) or Cyclosporine A (Sandimmun Neoral®)
- ClinicalTrials.gov ID
- NCT00148252
- Acronym / sponsor ID
- NILS 02-08144
- Conditions
- Renal Transplantation
- Keywords
- Calcineurin, reduction, immunosuppression, cyclosporine A, mycophenolate mofetil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To high rejection rate in CsA withdrawal arm
- Enrolment
- 298 participants
- Lead sponsor
- University of Oslo School of PharmacyUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Nov 2005 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 7 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.
To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy
Detailed description
To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy.
Secondly to examine safety following withdrawal of CsA or MMF, respectively, by the following parameters:
- Biopsy verified acute rejection episodes, time to first rejection and number of steroid resistant rejection episodes within 12 months.
- Hematology (Hb, WBC, platelets) abnormalities within 12 months.
- Graft and patient survival at 12 months and 5 years. Absolute difference in renal function between withdrawal groups at 12 months. Three monthly changes in renal function from drug withdrawal to 12 months. Change in dyslipidemia frequency from drug withdrawal to 12 months. Change in hypertension frequency from drug withdrawal to 12 months. Change in glucose tolerance from drug withdrawal to 12 months. Cumulative incidence of clinical infections resulting in hospitalization within 12 months.
Sub protocols will also examine the following aspects:
Cardiovascular: Homocysteine. Lipid peroxidation. Microvascular function and vasoactive parameters Quality of life (QoL): ESRD SCL-TM, SF-36 (short version) and EQ-5D (GI-checklist extended) questionnaires will be used.
Pharmacoeconomical evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Patients of either gender above 18 years of age at time of randomisation. 2. More than twelve months posttransplant. 3. Treated with an immunosuppressive protocol consisting of CsA, MMF and steroid from the time of discharge from the transplant clinic (e.g. 3 months posttransplant).
- 4. Kidney (only) transplant recipients with stable renal function (S-creatinine < 300 umol/L and an average increase in S-creatinine < 20% the last 6 months prior to inclusion) and without treated clinically and/or biopsy proven acute rejection episodes the last 6 months prior to inclusion.
- 5. No previous steroid resistant acute rejections (e.g. treated with ATG/OKT3). 6. Not more than two steroid sensitive acute rejections posttransplant. 7. Signed informed consent.
Key exclusion criteria (2 listed)
- 1. PRA positivity > 20%. 2. Concomitant therapy with other investigational drugs or prohibited medication specified in the protocol.
- 3. Life expectancy less than one year. 4. Acute illness or acute fungal, bacterial or viral infection at screening. 5. Unable and/or unlikely to follow the study protocol.
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 |
|---|---|---|
| Mycophenolate mofetil withdrawal | Drug | – |
| Cyclosporione A withdrawal | Drug | – |
Primary outcome
The primary efficacy endpoint is the absolute change in renal function from inclusion to 12 months post drug withdrawal, evaluated as GFR estimated from Nankivell's formula B and normalised for 1.73 m2 body-surface.
10 secondary outcomes
Graft and patient survival at 12 months and 5 years posttransplant.
Proportion of patients with biopsy-proven acute rejection or acute rejection (biopsy proven + presumptive) episodes within 12 months.
Incidence of HB, WBC, platelet abnormal values requiring clinical intervention within 12 months.
Incidence of need for additional immunosuppressive therapy at 12 months.
Absolute difference in renal function between treatment groups at 12 months, evaluated by Nankivell's formula (B).
Renal function (Nankivell's formula B) development over time (3 monthly) between treatment groups within 12 months.
Change in dyslipidemia frequency from drug withdrawal to 12 months.
Change in hypertension frequency from drug withdrawal to 12 months.
Change in glucose tolerance from drug withdrawal to 12 months.
Cumulative incidence of clinical infections resulting in hospitalization within 12 months.
Results and safety
The study was stopped early (reason given: To high rejection rate in CsA withdrawal arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
- Derived from this study: PubMed 23351013Asberg A, Apeland T, Reisaeter AV, Foss A, Leivestad T, Heldal K, Thorud LO, Eriksen BO, Hartmann A; NILS Study Group. Long-term outcomes after cyclosporine or mycophenolate withdrawal in kidney transplantation - results from an aborted trial. Clin Transplant. 2013 Mar-Apr;27(2):E151-6. doi: 10.1111/ctr.12076. Epub 2013 Jan 27.
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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.
Anders Åsberg, MSc study director
University of Oslo
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mycophenolate mofetil withdrawal and Cyclosporione A withdrawal in people with Renal Transplantation, run by University of Oslo School of Pharmacy at 9 sites in Norway.
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 2 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 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Norway. 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: To high rejection rate in CsA withdrawal arm). 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?
The primary efficacy endpoint is the absolute change in renal function from inclusion to 12 months post drug withdrawal, evaluated as GFR estimated from Nankivell's formula B and normalised for 1.73 m2 body-surface.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00148252, which also lists 1 linked publication.
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 Jun 2012.