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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00434590
• Other study ID #: CERL080AIT09
• Status: Terminated
• Phase: Phase 4
• First received: February 12, 2007
• Last updated: March 8, 2011
• Start date: March 2007
• Est. completion date: May 2008

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Enteric coated mycophenolate sodium (Myfortic®)

Locations

Country	Name	City	State
Italy	Novartis Investigative Site	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 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.	12 months	No
Secondary	Creatinine Clearance at 12 Months		12 months	No
Secondary	Serum Creatinine at 12 Months		12 months	No
Secondary	Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months		12 months	No
Secondary	Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months		12 months	No
Secondary	Chronic Rejection as Confirmed by Renal Biopsy at 12 Months		12 months	No