De Novo Renal Transplant Recipient.Phase 4NCT00166244
Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation
A Phase 4 study testing Mycophenolate Mofetil in people with De Novo Renal Transplant Recipient., run by Erasmus Medical Center at 67 sites in 19 countries.
Trial summary
Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- De Novo Renal Transplant Recipient.
- What is being tested?
- Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 901 participants
- Where
- 67 sitesin 19 countries
- Study dates
- May 2003to Apr 2006
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Renal transplant recipients who have completed their second birthday,
- Recipients from living (related or unrelated), cadaveric (non-heart beating or heart beating) donors,
- Single organ recipient (kidney only),
- Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/ml within 1 week prior to beginning MMF treatment. Effective contraception must be used before beginning therapy, during therapy and for 6 weeks following discontinuation of therapy, even where there has been a history of infertility, unless due to hysterectomy,
- Patients or patient's parent/guardian providing written informed consent,
- Patients co-operative and able to complete all the assessment procedures.
Who cannot join
- Patients receiving immunosuppressive therapy (except steroid treatment) within the preceding 28 days, except that immunosuppressive medication may be initiated up to 48 hours before transplantation. Furthermore, all patients should receive 1 g [adults] or 600 mg/m2 [paediatric patients] of MMF therapy within 6 hours prior to transplantation,
- PRA > 50% within 6 months prior to enrolment,
- Cold ischaemia time >48 hours,
- History of malignancy (except localised non-melanotic skin cancer) or the presence of any active malignancy at the time of transplant,
- Active peptic ulcer disease,
- Active infection,
Show all 15Show fewer
- Mandatory intake of prohibited drugs or it is probable that the patient will require treatment with such drugs after transplant,
- Pregnant or lactating females,
- Women of child-bearing potential not willing to use a reliable form of contraception,
- Patient is allergic or intolerant to polysorbate 80 (TWEEN), phenylalanine (aspartame), steroids, MMF, MPA, tacrolimus or cyclosporin,
- Patient or donor with positive tests for HIV or hepatitis B surface antigen,
- Patients with liver cirrhosis or clinical evidence of portal hypertension or other indication of moderate or severe liver disease. (Note: it is strongly recommended that patients with hepatitis C have a liver biopsy performed prior to transplantation),
- Incompatible ABO blood type and/or positive crossmatch,
- Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication with the investigator or with study procedures,
- Patients whose laboratory results reveal severe anaemia (as defined by a haemoglobin value <6 mmol/L [9.7 g/dL] for adults receiving erythropoietin, <4.1 mmol/L [6.6 g/dL] for paediatric patients [regardless of erythropoietin treatment]), leukopenia (as defined by a WBC value of <2500/mm3) or thrombocytopenia (as defined by a platelet count of <75,000/mm3).
Trial locations and contacts
67 sites in 19 countries.
67 sites in 19 countries
France15 sites
Hopital Pellegrin, C.H.R.de Bordeaux
Bordeaux, 33076
Hospital du Bocage
Dijon, 21000
CHU de Grenoble
Grenoble, 38043
CHU Kremlin Bicêtre
Le Kremlin-Bicêtre, 94275
Hopital Calmette
Lille, 59037
Hopital Jeanne de Flandres
Lille, 59037
Centre Hospitalier Regional Universitaire
Limoges, 87042
CHU Hotel Dieu
Nantes, 44093
Hopital Necker
Paris, 75015
Hopital Tenon
Paris, 75020
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Hopital Foch
Suresnes, 92151
CHU Purpan
Toulouse, 31059
CHU Rangueil
Toulouse, 31059
CHU de Nancy-Brabois
Vandœuvre-lès-Nancy, 54511
Spain14 sites
Hospital Infanta Christa
Badajoz, 06080
Hospital Del Mar
Barcelona, 08003
Valle de Hebron
Barcelona, 08035
Hospital Sant Joan de Deu
Barcelona, 8950
Hospital Reina Sofia
Córdoba, 14004
Hospital de las Nieves
Granada, 18014
Hospital Ramon Y Cajal
Madrid, 28034
Fundacion Jimenez Diaz
Madrid, 28040
Hospital Clinico San Carlos
Madrid, 28040
La Paz
Madrid, 28046
Hospital Son Dureta
Palma de Mallorca, 07014
Complejo Hospitalario Univeritario de Santiago
Santiago de Compostela, 15706
Hospital Virgen del Rocio
Seville, 41013
Hospital Dr. Peset
Valencia
Australia7 sites
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Monash Medical Centre
Clayton, Victoria, 3168
St Vincent's Hospital
Melbourne, Victoria, 3065
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
John Hunter Hospital
New Lambton, New South Wales, 2305
Royal Melbourne Hospital
Parkville, Victoria, 3052
Royal Perth Hospital
Perth, Western Australia, 6847
Germany6 sites
Universitatsklinikum Charite
Berlin, 10098
Stadt Kliniken Koln
Cologne, 51009
Chirurgische Universitätsklinik
Freiburg im Breisgau, 79106
Universitatsklinikum Heidelberg
Heidelberg, 69120
University of Heidelberg
Heidelberg, 69120
University Hospital Wurzburg
Würzburg, 97080
Sweden3 sites
University Hospital, Malmo
Malmö, 205 02
Karolinska University Hospital, Huddinge
Stockholm, 141 86
University Hospital A
Uppsala, 751 85
United Kingdom3 sites
Royal Free Hospital
London, NW3 2QG
Guys and St Thomas's Hospital
London, SE1 9RT
St George's Hospital
London, SW17 ORE
Venezuela3 sites
Hospital "Miguel Perez Carreno"
Caracas
Hospital Universitario de Caracas
Caracas
Hospital Universitario de Maracaibo
Maracaibo
China2 sites
West China Hospital of Sichuan University
Chengdu, Sichuan
Ruijin Hospital
Shanghai, Shanghai Municipality, 200001
Netherlands2 sites
Leids Universitair Medisch Centrum
Leiden, 2333
Erasmus Medical Center Rotterdam
Rotterdam, 3000
Poland2 sites
Institute of Transplantology, Medical University of Warsaw
Warsaw, 02-006
Children's Memorial Health Institute
Warsaw, 04-736
About this study
Official title: An Open, Prospective, Randomised, Controlled, Multi-Center Study Comparing Fixed Dose vs Concentration Controlled Mycophenolate Mofetil Regimens for de Novo Patients Following Transplantation
Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.
Read the detailed description
For treatment with mycophenolate mofetil the contribution of TDM still has to be determined, although circumstantial evidence suggests the measurement of mycophenolic acid plasma concentrations adds to patient management.
A concerted effort to test the hypothesis that TDM will improve outcome in mycophenolate mofetil therapy in a prospective randomised trial is to be made if we want to have a solid base for the continued measurements of mycophenolic acid concentrations in the future. This trial aims to demonstrate the added value of TDM for mycophenolic acid, by comparing fixed dose treatment with concentration controlled mycophenolate mofetil treatment in kidney transplant recipients.
- Conditions
- De Novo Renal Transplant Recipient.
- Being tested
- Mycophenolate Mofetil
- Keywords
- Mycophenolate mofetil, Therapeutic Drug Monitoring, Adult kidney transplantation, Paediatric kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called CellCept
1 g for adult patients and 300 mg/m2 for paediatric patients. Fixed dose arm: 1 g twice a day (bid) for adults and 600mg/m2 bid for paediatric patients.
Concentration controlled arm: initial dose will be 1 g bid for adults and 600mg/m2 bid for paediatric patients. Abbreviated AUCs (taken at timepoints: 0, 30min and 120min in fasted patients) on Days 3 and 10, Week 4, Months 3, 6 and 12 will be performed to determine mycophenolic acid levels in plasma.
| Study group | Role | What they receive |
|---|---|---|
| Fixed Dose | Active comparator | 1 g MMF twice-daily (bid) for adults or 600 mg/m2 bid for paediatric patients. Treatment to be given orally unless it is not possible, in which case it is administered via intravenous (iv) infusion. Receives: Drug: Mycophenolate Mofetil |
| Concentration Controlled | Active comparator | 1 g MMF bid for adults or 600 mg/m2 bid for paediatric patients. Thereafter, MMF doses will be adjusted to MPA AUC0-12 between 30-60mg.h/L based on 3-point abbreviated AUCs (taken at timepoints: 0, 30 min and 120 min always in fasted patients, except for pediatric patients on concomitant tacrolimus) on Days 3 and 10, Week 4, Months 3, 6 and 12 will be performed to determine MPA levels in plasma. Receives: Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure including the occurrence of the first one of any of the following: biopsy-proven acute rejection, graft loss, death or discontinuation of MMF therapy during the first 12 months following transplantation.
Measured: 12 Months
Secondary outcomes (8)
Proportion of patients treated for acute rejection during the first 3, 6, 12 months post-transplantation,
Measured: 3, 6 and 12 Months
Time to first acute rejection,
Measured: 12 Months
Number of acute rejection episodes per patient in the first year post-transplantation,
Measured: 12 Months
Overall treatment outcome at 12 months post-transplantation which is composed of any one of the following:
Measured: 12 Months
Graft loss,
Measured: 12 Months
Death,
Measured: 12 Months
Discontinuation of MMF therapy,
Measured: 12 Months
Patient lost to follow-up.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionMar 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for De Novo Renal Transplant Recipient.Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Teun van Gelder, Dr, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166244
- Sponsor's protocol ID
- FDCC
- Status last verified
- Feb 2009
- First submitted
- 9 Sep 2005
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Gelder T, Hilbrands LB, Vanrenterghem Y, Weimar W, de Fijter JW, Squifflet JP, Hene RJ, Verpooten GA, Navarro MT, Hale MD, Nicholls AJ. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation. 1999 Jul 27;68(2):261-6. doi: 10.1097/00007890-199907270-00018.
PubMed 10440399van Gelder T, Silva HT, de Fijter JW, Budde K, Kuypers D, Tyden G, Lohmus A, Sommerer C, Hartmann A, Le Meur Y, Oellerich M, Holt DW, Tonshoff B, Keown P, Campbell S, Mamelok RD. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: the fixed-dose concentration-controlled trial. Transplantation. 2008 Oct 27;86(8):1043-51. doi: 10.1097/TP.0b013e318186f98a.
PubMed 18946341Hocker B, van Gelder T, Martin-Govantes J, Machado P, Tedesco H, Rubik J, Dehennault M, Garcia Meseguer C, Tonshoff B; FDCC Study Group. Comparison of MMF efficacy and safety in paediatric vs. adult renal transplantation: subgroup analysis of the randomised, multicentre FDCC trial. Nephrol Dial Transplant. 2011 Mar;26(3):1073-9. doi: 10.1093/ndt/gfq450. Epub 2010 Jul 28.
PubMed 20670958van Gelder T, Tedesco Silva H, de Fijter JW, Budde K, Kuypers D, Arns W, Soulillou JP, Kanellis J, Zelvys A, Ekberg H, Holzer H, Rostaing L, Mamelok RD. Renal transplant patients at high risk of acute rejection benefit from adequate exposure to mycophenolic acid. Transplantation. 2010 Mar 15;89(5):595-9. doi: 10.1097/TP.0b013e3181ca7d84.
PubMed 20124953van Schaik RH, van Agteren M, de Fijter JW, Hartmann A, Schmidt J, Budde K, Kuypers D, Le Meur Y, van der Werf M, Mamelok R, van Gelder T. UGT1A9 -275T>A/-2152C>T polymorphisms correlate with low MPA exposure and acute rejection in MMF/tacrolimus-treated kidney transplant patients. Clin Pharmacol Ther. 2009 Sep;86(3):319-27. doi: 10.1038/clpt.2009.83. Epub 2009 Jun 3.
PubMed 19494809
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Randomised, Controlled, Multi-Center Study Comparing Fixed Dose vs Concentration Controlled Mycophenolate Mofetil Regimens for de Novo Patients Following Transplantation
- ClinicalTrials.gov ID
- NCT00166244
- Acronym / sponsor ID
- FDCC
- Conditions
- De Novo Renal Transplant Recipient.
- Keywords
- Mycophenolate mofetil, Therapeutic Drug Monitoring, Adult kidney transplantation, Paediatric kidney transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- May 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 14 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.
Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.
Detailed description
For treatment with mycophenolate mofetil the contribution of TDM still has to be determined, although circumstantial evidence suggests the measurement of mycophenolic acid plasma concentrations adds to patient management.
A concerted effort to test the hypothesis that TDM will improve outcome in mycophenolate mofetil therapy in a prospective randomised trial is to be made if we want to have a solid base for the continued measurements of mycophenolic acid concentrations in the future. This trial aims to demonstrate the added value of TDM for mycophenolic acid, by comparing fixed dose treatment with concentration controlled mycophenolate mofetil treatment in kidney transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed Dose | Active comparator | Drug: Mycophenolate Mofetil1 g MMF twice-daily (bid) for adults or 600 mg/m2 bid for paediatric patients. Treatment to be given orally unless it is not possible, in which case it is administered via intravenous (iv) infusion. |
| Concentration Controlled | Active comparator | Drug: Mycophenolate Mofetil1 g MMF bid for adults or 600 mg/m2 bid for paediatric patients. Thereafter, MMF doses will be adjusted to MPA AUC0-12 between 30-60mg.h/L based on 3-point abbreviated AUCs (taken at timepoints: 0, 30 min and 120 min always in fasted patients, except for pediatric patients on concomitant tacrolimus) on Days 3 and 10, Week 4, Months 3, 6 and 12 will be performed to determine MPA levels in plasma. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Renal transplant recipients who have completed their second birthday,
- Recipients from living (related or unrelated), cadaveric (non-heart beating or heart beating) donors,
- Single organ recipient (kidney only),
- Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/ml within 1 week prior to beginning MMF treatment. Effective contraception must be used before beginning therapy, during therapy and for 6 weeks following discontinuation of therapy, even where there has been a history of infertility, unless due to hysterectomy,
- Patients or patient's parent/guardian providing written informed consent,
Key exclusion criteria (15 listed)
- Patients receiving immunosuppressive therapy (except steroid treatment) within the preceding 28 days, except that immunosuppressive medication may be initiated up to 48 hours before transplantation. Furthermore, all patients should receive 1 g [adults] or 600 mg/m2 [paediatric patients] of MMF therapy within 6 hours prior to transplantation,
- PRA > 50% within 6 months prior to enrolment,
- Cold ischaemia time >48 hours,
- History of malignancy (except localised non-melanotic skin cancer) or the presence of any active malignancy at the time of transplant,
- Active peptic ulcer disease,
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 MofetilAlso: CellCept1 g for adult patients and 300 mg/m2 for paediatric patients. Fixed dose arm: 1 g twice a day (bid) for adults and 600mg/m2 bid for paediatric patients. Concentration controlled arm: initial dose will be 1 g bid for adults and 600mg/m2 bid for paediatric patients. Abbreviated AUCs (taken at timepoints: 0, 30min and 120min in fasted patients) on Days 3 and 10, Week 4, Months 3, 6 and 12 will be performed to determine mycophenolic acid levels in plasma. | Drug | Concentration Controlled, Fixed Dose |
Primary outcome
Treatment failure including the occurrence of the first one of any of the following: biopsy-proven acute rejection, graft loss, death or discontinuation of MMF therapy during the first 12 months following transplantation.
Time frame: 12 Months
8 secondary outcomes
Proportion of patients treated for acute rejection during the first 3, 6, 12 months post-transplantation,
Time frame: 3, 6 and 12 Months
Time to first acute rejection,
Time frame: 12 Months
Number of acute rejection episodes per patient in the first year post-transplantation,
Time frame: 12 Months
Overall treatment outcome at 12 months post-transplantation which is composed of any one of the following:
Time frame: 12 Months
Graft loss,
Time frame: 12 Months
Death,
Time frame: 12 Months
Discontinuation of MMF therapy,
Time frame: 12 Months
Patient lost to follow-up.
Time frame: 12 Months
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 12 Feb 2009.
- Background: PubMed 10440399van Gelder T, Hilbrands LB, Vanrenterghem Y, Weimar W, de Fijter JW, Squifflet JP, Hene RJ, Verpooten GA, Navarro MT, Hale MD, Nicholls AJ. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation. 1999 Jul 27;68(2):261-6. doi: 10.1097/00007890-199907270-00018.
- Results publication: PubMed 18946341van Gelder T, Silva HT, de Fijter JW, Budde K, Kuypers D, Tyden G, Lohmus A, Sommerer C, Hartmann A, Le Meur Y, Oellerich M, Holt DW, Tonshoff B, Keown P, Campbell S, Mamelok RD. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: the fixed-dose concentration-controlled trial. Transplantation. 2008 Oct 27;86(8):1043-51. doi: 10.1097/TP.0b013e318186f98a.
- Derived from this study: PubMed 20670958Hocker B, van Gelder T, Martin-Govantes J, Machado P, Tedesco H, Rubik J, Dehennault M, Garcia Meseguer C, Tonshoff B; FDCC Study Group. Comparison of MMF efficacy and safety in paediatric vs. adult renal transplantation: subgroup analysis of the randomised, multicentre FDCC trial. Nephrol Dial Transplant. 2011 Mar;26(3):1073-9. doi: 10.1093/ndt/gfq450. Epub 2010 Jul 28.
- Derived from this study: PubMed 20124953van Gelder T, Tedesco Silva H, de Fijter JW, Budde K, Kuypers D, Arns W, Soulillou JP, Kanellis J, Zelvys A, Ekberg H, Holzer H, Rostaing L, Mamelok RD. Renal transplant patients at high risk of acute rejection benefit from adequate exposure to mycophenolic acid. Transplantation. 2010 Mar 15;89(5):595-9. doi: 10.1097/TP.0b013e3181ca7d84.
- Derived from this study: PubMed 19494809van Schaik RH, van Agteren M, de Fijter JW, Hartmann A, Schmidt J, Budde K, Kuypers D, Le Meur Y, van der Werf M, Mamelok R, van Gelder T. UGT1A9 -275T>A/-2152C>T polymorphisms correlate with low MPA exposure and acute rejection in MMF/tacrolimus-treated kidney transplant patients. Clin Pharmacol Ther. 2009 Sep;86(3):319-27. doi: 10.1038/clpt.2009.83. Epub 2009 Jun 3.
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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.
Teun van Gelder, Dr principal investigator
Erasmus Medical Center
67 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mycophenolate Mofetil in people with De Novo Renal Transplant Recipient., run by Erasmus Medical Center at 67 sites in 19 countries.
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 6 inclusion and 15 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 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in France, Spain, Australia, Germany, Sweden and 14 more countries. 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 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.
What does the primary outcome measure?
Treatment failure including the occurrence of the first one of any of the following: biopsy-proven acute rejection, graft loss, death or discontinuation of MMF therapy during the first 12 months following transplantation. (time frame: 12 Months). 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 NCT00166244, which also lists 5 linked publications.
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 12 Feb 2009.