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Trial record 87 of 1164 for:    MYCOPHENOLIC ACID

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

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ClinicalTrials.gov Identifier: NCT00434590
Recruitment Status : Terminated (The study has been stopped because of the lack of enrollment)
First Posted : February 13, 2007
Results First Posted : April 7, 2011
Last Update Posted : April 7, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Kidney Transplantation
Intervention Drug: Enteric coated mycophenolate sodium (Myfortic®)
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Full Dose Myfortic® and Reduced Dose Neoral® Standard Dose of Myfortic® and Standard Dose of CsA-ME
Hide Arm/Group Description 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 Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
Period Title: Overall Study
Started 5 5
Completed 0 [1] 0
Not Completed 5 5
Reason Not Completed
Administrative problems             5             5
[1]
All patients randomized had study discontinued because of premature study termination.
Arm/Group Title Full Dose Myfortic® and Reduced Dose Neoral® Standard Dose of Myfortic® and Standard Dose of CsA-ME Total
Hide Arm/Group Description 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 Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME. Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
52.4  (13.8) 58.0  (12.5) 55.2  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
4
  80.0%
3
  60.0%
7
  70.0%
Male
1
  20.0%
2
  40.0%
3
  30.0%
1.Primary Outcome
Title Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months
Hide Description 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated without analysis (small sample size).
Arm/Group Title Full Dose Myfortic® and Reduced Dose Neoral® Standard Dose of Myfortic® and Standard Dose of CsA-ME
Hide Arm/Group Description:
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
Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Creatinine Clearance at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Serum Creatinine at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Chronic Rejection as Confirmed by Renal Biopsy at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Full Dose Myfortic® and Reduced Dose Neoral® Standard Dose of Myfortic® and Standard Dose of CsA-ME
Hide Arm/Group Description 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 Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
All-Cause Mortality
Full Dose Myfortic® and Reduced Dose Neoral® Standard Dose of Myfortic® and Standard Dose of CsA-ME
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Full Dose Myfortic® and Reduced Dose Neoral® Standard Dose of Myfortic® and Standard Dose of CsA-ME
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Full Dose Myfortic® and Reduced Dose Neoral® Standard Dose of Myfortic® and Standard Dose of CsA-ME
Affected / at Risk (%) Affected / at Risk (%)
Total   2/5 (40.00%)   4/5 (80.00%) 
Blood and lymphatic system disorders     
Leukopenia  1  1/5 (20.00%)  0/5 (0.00%) 
Eye disorders     
Conjunctival irritation  1  0/5 (0.00%)  1/5 (20.00%) 
Gastrointestinal disorders     
Haemorrhoids  1  0/5 (0.00%)  1/5 (20.00%) 
General disorders     
Oedema peripheral  1  0/5 (0.00%)  1/5 (20.00%) 
Infections and infestations     
Nasopharyngitis  1  0/5 (0.00%)  1/5 (20.00%) 
Otitis media chronic  1  1/5 (20.00%)  0/5 (0.00%) 
Urinary tract infection  1  0/5 (0.00%)  2/5 (40.00%) 
Injury, poisoning and procedural complications     
Upper limb fracture  1  0/5 (0.00%)  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/5 (0.00%)  1/5 (20.00%) 
Vascular disorders     
Hypertension  1  0/5 (0.00%)  1/5 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00434590     History of Changes
Other Study ID Numbers: CERL080AIT09
First Submitted: February 12, 2007
First Posted: February 13, 2007
Results First Submitted: December 13, 2010
Results First Posted: April 7, 2011
Last Update Posted: April 7, 2011