A One-year, Open Label Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients.

Kidney Transplantation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154245
• Other study ID #: CERL080ATW01
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: February 21, 2017
• Start date: January 2004
• Est. completion date: March 2006

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The study will consist of a 12-month open-label treatment period on EC-MPS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Males and females aged 18-75 years. Recipients of de novo cadaveric, living unrelated or living related kidney transplants

Exclusion Criteria:

Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ.

Patients who are recipients of A-B-O incompatible transplants. Patients with a historical or current peak PRA of 50%. Patients with already existing antibodies against the HLA-type of the receiving transplant.

Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin 3 times UNL).

Patients who are HIV or Hepatitis B surface antigen positive. Patients with any known hypersensitivity to mycophenolic acid, MMF, EC-MPS, other components of the formulation (e.g. lactose).

Patients with thrombocytopenia (75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.

Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Enteric-Coated Mycophenolate sodium (EC-MPS)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft function 6 months post transplantation
Secondary	Incidence of biopsy proven acute rejection, graft loss or death within 6 and 12 months post transplantation
Secondary	Incidence of biopsy proven acute rejection within 6 and 12 months post transplantation
Secondary	Time to first biopsy-proven acute rejection
Secondary	Severity of biopsy-proven acute rejection
Secondary	Graft survival and patient survival at 6 and 12 months

External Links

•   Results for CERL080ATW01 from the Novartis Clinical Trials website