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CompletedNCT00238953Updated Feb 23, 2017

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

A Phase 4 interventional study of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplantation, sponsored by Novartis. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Novartis · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Transplantation

Keywords

  • Kidney transplantation
  • enteric-coated mycophenolate sodium
03

In context

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All

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

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

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    EC MPS

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

Interventions

  • DrugEnteric-Coated Mycophenolate Sodium (EC-MPS)
06

What researchers measure

Primary outcomes

  1. 6 Month evaluation

  2. patient and graft survival

  3. acute rejection (suspected or biopsy confirmed)

  4. graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate),

  5. infections, adverse events, serious adverse events.

Secondary outcomes

  1. Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation

07

Study locations

1 site
  • Novartis
    Basel, Switzerland
08

References and documents

Publications

  • Wyzgal J, Niemczyk M, Ziolkowski 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. doi: 10.1016/j.transproceed.2007.08.071. PubMed 18021971 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00238953
Lead sponsor
Novartis
First posted
Oct 14, 2005
Start date
Feb 2005
Primary completion
Jun 2006
Completion
Jun 2006
Last update
Feb 23, 2017

Study contacts

Novartis
study director · Novartis
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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