A Phase 3 interventional study of Enteric-coated mycophenolate sodium (EC-MPS) and Prednisone in Renal Transplantation, sponsored by Novartis. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-04-21.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated to receive either EC-MPS or steroids in combination with EC-MPS. Patients of both treatment groups will receive monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.
Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
Drug: Enteric-coated mycophenolate sodium (EC-MPS)
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
Drug: Enteric-coated mycophenolate sodium (EC-MPS) · Drug: Prednisone
An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day.
Also known as: Myfortic
Oral tablets
Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation
Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.
Time frame: 6 months post transplantation
The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months
If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection.
Time frame: Month 6
Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months
A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.
Time frame: Month 3
Number of Participants With Subclinical Histological Rejections
The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies.
Time frame: Month 3
Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status
The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status. Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. Slow graft function is defined as a serum creatinine value \> 250 µmol/L at day 5.
Time frame: Month 3
Number of Participants Requiring Steroids in Non-steroid Treatment Group
Time frame: Months 3 and 6
| Milestone | Without Steroids | With Steroids |
|---|---|---|
| Started | 112 | 110 |
| Completed | 84 | 82 |
| Not completed | 28 | 28 |
| Withdrew: Adverse event | 9 | 11 |
| Withdrew: Lack of efficacy | 11 | 9 |
| Withdrew: Death | 3 | 5 |
| Withdrew: Graft loss | 5 | 3 |
Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.
| Number of participants | Without Steroids | With Steroids |
|---|---|---|
| Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation | 20 | 16 |
If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection.
| Number of participants | Without Steroids | With Steroids |
|---|---|---|
| Biopsy Proven Acute Rejection | 13 | 8 |
| Graft Loss | 5 | 3 |
| Death | 2 | 5 |
| Loss to Follow-up | 0 | 0 |
| Acute Rejection | 37 | 21 |
| Treated Acute Rejection | 36 | 19 |
A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.
| Number of participants | Without Steroids | With Steroids |
|---|---|---|
| Treatment Failure | 17 | 8 |
| Biopsy Proven Acute Rejection | 10 | 5 |
| Graft Loss | 5 | 1 |
| Death | 2 | 2 |
| Loss to Follow-up | 0 | 0 |
| Acute Rejection | 32 | 19 |
| Treated Acute Rejection | 31 | 16 |
The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies.
| Number of participants | Without Steroids | With Steroids |
|---|---|---|
| Sample quality inadequate | 7 | 6 |
| Subclinical rejection | 12 | 17 |
| Borderline lesions | 2 | 5 |
| BPAR | 10 | 12 |
The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status. Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. Slow graft function is defined as a serum creatinine value \> 250 µmol/L at day 5.
| Number of participants | Without Steroids | With Steroids |
|---|---|---|
| Delayed Graft Function [N= 25,24] | 8 | 4 |
| Slow Graft Function [N= 36,23] | 6 | 1 |
| Immediate Graft Function [N= 51,63] | 3 | 3 |
| Number of participants | Without Steroids |
|---|---|
| 3 Months | 25 |
| 6 Months | 20 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Without Steroids | — | 72/112 (64.3%) | 104/112 (92.9%) |
| With Steroids | — | 69/110 (62.7%) | 107/110 (97.3%) |
| Event | Without Steroids | With Steroids |
|---|---|---|
| Renal failure acuteRenal and urinary disorders | 12/112 | 10/110 |
| PyrexiaGeneral disorders | 10/112 | 10/110 |
| Cytomegalovirus infectionInfections and infestations | 6/112 | 10/110 |
| Blood creatinine increasedInvestigations | 10/112 | 8/110 |
| PyelonephritisInfections and infestations | 5/112 | 9/110 |
| Graft dysfunctionInjury, poisoning and procedural complications | 8/112 | 8/110 |
| DiarrhoeaGastrointestinal disorders | 5/112 | 6/110 |
| Abdominal painGastrointestinal disorders | 2/112 | 5/110 |
| LymphoceleVascular disorders | 3/112 | 5/110 |
| ChillsGeneral disorders | 5/112 | 3/110 |
| Event | Without Steroids | With Steroids |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 60/112 | 56/110 |
| Urinary tract infectionInfections and infestations | 34/112 | 39/110 |
| HyperglycaemiaMetabolism and nutrition disorders | 30/112 | 31/110 |
| Oedema peripheralGeneral disorders | 27/112 | 27/110 |
| DyslipidaemiaMetabolism and nutrition disorders | 10/112 | 21/110 |
| LeukopeniaBlood and lymphatic system disorders | 21/112 | 12/110 |
| InsomniaPsychiatric disorders | 20/112 | 18/110 |
| HypertensionVascular disorders | 20/112 | 17/110 |
| HyperkalaemiaMetabolism and nutrition disorders | 19/112 | 9/110 |
| Graft dysfunctionInjury, poisoning and procedural complications | 16/112 | 18/110 |
| Age Continuous(years) | Without Steroids | With Steroids | Total |
|---|---|---|---|
| Mean | 51.0 ± 10.24 | 50.9 ± 11.91 | 51.0 ± 11.07 |
| Age, Customized(Participants) | Without Steroids | With Steroids | Total |
|---|---|---|---|
| < 45 years | 33 | 25 | 58 |
| 45-60 years | 56 | 58 | 114 |
| >= 60 years | 23 | 27 | 50 |
| Sex: Female, Male(Participants) | Without Steroids | With Steroids | Total |
|---|---|---|---|
| Female | 36 | 40 | 76 |
| Male | 76 | 70 | 146 |
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