Trial Outcomes & Findings for Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients (NCT NCT00434590)

NCT ID: NCT00434590

Last Updated: 2011-04-07

Results Overview

The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2011-04-07

Participant Flow

Participant milestones

Measure	Full Dose Myfortic® and Reduced Dose Neoral® The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME	Standard Dose of Myfortic® and Standard Dose of CsA-ME Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
Overall Study STARTED	5	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Full Dose Myfortic® and Reduced Dose Neoral® The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME	Standard Dose of Myfortic® and Standard Dose of CsA-ME Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
Overall Study Administrative problems	5	5

Baseline Characteristics

Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients

Baseline characteristics by cohort

Measure	Full Dose Myfortic® and Reduced Dose Neoral® n=5 Participants The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME	Standard Dose of Myfortic® and Standard Dose of CsA-ME n=5 Participants Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.	Total n=10 Participants Total of all reporting groups
Age Continuous	52.4 Years STANDARD_DEVIATION 13.8 • n=5 Participants	58.0 Years STANDARD_DEVIATION 12.5 • n=7 Participants	55.2 Years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Study was terminated without analysis (small sample size).

The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

Adverse Events

Full Dose Myfortic® and Reduced Dose Neoral®

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard Dose of Myfortic® and Standard Dose of CsA-ME

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Full Dose Myfortic® and Reduced Dose Neoral® n=5 participants at risk The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME	Standard Dose of Myfortic® and Standard Dose of CsA-ME n=5 participants at risk Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
Blood and lymphatic system disorders Leukopenia	20.0% 1/5	0.00% 0/5
Eye disorders Conjunctival irritation	0.00% 0/5	20.0% 1/5
Gastrointestinal disorders Haemorrhoids	0.00% 0/5	20.0% 1/5
General disorders Oedema peripheral	0.00% 0/5	20.0% 1/5
Infections and infestations Nasopharyngitis	0.00% 0/5	20.0% 1/5
Infections and infestations Otitis media chronic	20.0% 1/5	0.00% 0/5
Infections and infestations Urinary tract infection	0.00% 0/5	40.0% 2/5
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/5	20.0% 1/5
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5	20.0% 1/5
Vascular disorders Hypertension	0.00% 0/5	20.0% 1/5

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER