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NCT00238953 Clinical Trial

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

Renal Transplantation Clinical Trial

Official title:
A Prospective, Open Label Protocol to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00238953
Other study ID # CERL080APL01
Secondary ID
Status Completed
Phase Phase 4
First received October 12, 2005
Last updated February 21, 2017
Start date February 2005
Est. completion date June 2006

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion criteria:

- Male and females aged 18 to 75

- Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression

Exclusion criteria:

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

- Patients with any known hypersensitivity to MPA, EC-MPS or 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 inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Switzerland Novartis Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Wyzgal J, Niemczyk M, Ziólkowski J, Durlik M, Wiecek A. Results of a 6-month, multicenter, open-label, prospective study concerning efficacy and safety of mycophenolate sodium in de novo kidney transplant recipients. Transplant Proc. 2007 Nov;39(9):2730-2 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 6 Month evaluation
Primary patient and graft survival
Primary acute rejection (suspected or biopsy confirmed)
Primary graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate),
Primary infections, adverse events, serious adverse events.
Secondary Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation
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