Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

Kidney Transplantation Clinical Trial

Official title:

A Six-month, Prospective, Multicenter, Open Label, Parallel, Randomized Study of the Safety, Tolerability and Efficacy of EC-MPS With Basiliximab, Corticosteroids and Two Different Levels of Tacrolimus in de Novo Renal Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229138
• Other study ID #: CERL080A2409
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2005
• Last updated: February 3, 2017
• Start date: September 2005
• Est. completion date: March 2007

Study information

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

Clinical Trial Summary

This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.

• The renal cold ischemic time (CIT) must be <30 hours

• The age of the donor must be between 10 and 65 years

Exclusion Criteria

• Patients who have previously received an organ transplant

• Patients who are recipients of a multiple organ transplants

• Recipients of non heart-beating donor organs

• ABO incompatibility against the donor

Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• EC-MPS, Tacrolimus

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chan L, Andres A, Bunnapradist S, Gugliuzza K, Parasuraman R, Peddi VR, Cassuto E, Hart M. Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS. J Transplant. 2012 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function at 6 months posttransplant as measured by glomerular filtration rate		6 months
Secondary	Efficacy as measured by combined incidence of biopsy proven acute rejection episodes, graft loss, and death at 6 months
Secondary	Renal function as measured by calculated creatinine clearance
Secondary	Cockcroft-Gaultand serum creatinine at 6 months
Secondary	Gastrointestinal tolerability as measured by gastrointestinal
Secondary	symptom rating scale (GSRS) at various time points
Secondary	Safety as measured by incidence of adverse events
Secondary	Effects on glucose metabolism at months 3 and 6 after transplantation.

External Links

•   Results for CERL080A2409 from the Novartis Clinical Trials website