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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00434590
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The study will evaluate kidney graft function in maintenance renal transplant patients.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: Enteric coated mycophenolate sodium (Myfortic®)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Controlled, Randomized, Parallel Group Study to Assess Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Enteric coated mycophenolate sodium (Myfortic®); Other Names: Myfortic
Active Comparator: 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.	Drug: Enteric coated mycophenolate sodium (Myfortic®); Other Names: Myfortic

Outcome Measures

Primary Outcome Measures

1. Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months [12 months]

   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.

Secondary Outcome Measures

1. Creatinine Clearance at 12 Months [12 months]

2. Serum Creatinine at 12 Months [12 months]

3. Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months [12 months]

4. Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months [12 months]

5. Chronic Rejection as Confirmed by Renal Biopsy at 12 Months [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion criteria:

• Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years

• Age > 18 yrs

• Adequate and stable renal function

• Informed consent.

Exclusion criteria:

• Kidney transplant combined with other organs;

• Significant proteinuria

• Severe ongoing infections;

• Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years;

• Relapse of the end-stage renal disease on the transplanted kidney;

• Leucopenia, thrombocytopenia or severe anemia;

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Bologna		Italy

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00434590
• Other Study ID Numbers: CERL080AIT09
• First Posted: Feb 13, 2007
• Last Update Posted: Apr 7, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Kidney Transplantation; Mycophenolic Acid; Immunosuppression; Cyclosporine
• Additional relevant MeSH terms: Mycophenolic Acid

Study Results

Participant Flow

Arm/Group Title	Full Dose Myfortic® and Reduced Dose Neoral®	Standard Dose of Myfortic® and Standard Dose of CsA-ME
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	0
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Full Dose Myfortic® and Reduced Dose Neoral®	Standard Dose of Myfortic® and Standard Dose of CsA-ME	Total
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 Participants	5	5	10
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	52.4 (13.8)	58.0 (12.5)	55.2 (12.8)
Sex: Female, Male (Count of Participants)
Female	4 80%	3 60%	7 70%
Male	1 20%	2 40%	3 30%

Outcome Measures

1. Primary Outcome

Title	Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months
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

Outcome Measure Data

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
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.
Measure Participants	0	0

2. Secondary Outcome

Title	Creatinine Clearance at 12 Months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Serum Creatinine at 12 Months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Chronic Rejection as Confirmed by Renal Biopsy at 12 Months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Full Dose Myfortic® and Reduced Dose Neoral®		Standard Dose of Myfortic® and Standard Dose of CsA-ME
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Full Dose Myfortic® and Reduced Dose Neoral®		Standard Dose of Myfortic® and Standard Dose of CsA-ME
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Full Dose Myfortic® and Reduced Dose Neoral®		Standard Dose of Myfortic® and Standard Dose of CsA-ME
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/5 (40%)		4/5 (80%)
Blood and lymphatic system disorders
Leukopenia	1/5 (20%)		0/5 (0%)
Eye disorders
Conjunctival irritation	0/5 (0%)		1/5 (20%)
Gastrointestinal disorders
Haemorrhoids	0/5 (0%)		1/5 (20%)
General disorders
Oedema peripheral	0/5 (0%)		1/5 (20%)
Infections and infestations
Nasopharyngitis	0/5 (0%)		1/5 (20%)
Otitis media chronic	1/5 (20%)		0/5 (0%)
Urinary tract infection	0/5 (0%)		2/5 (40%)
Injury, poisoning and procedural complications
Upper limb fracture	0/5 (0%)		1/5 (20%)
Respiratory, thoracic and mediastinal disorders
Cough	0/5 (0%)		1/5 (20%)
Vascular disorders
Hypertension	0/5 (0%)		1/5 (20%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.