NCT00238953

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

October 12, 2005

Last Update Submit

February 21, 2017

Conditions

Renal Transplantation

Keywords

Kidney transplantationenteric-coated mycophenolate sodium

Outcome Measures

Primary Outcomes (5)

  • 6 Month evaluation

  • patient and graft survival

  • acute rejection (suspected or biopsy confirmed)

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

  • 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

Study Arms (1)

EC MPS

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

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)DRUG
EC MPS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 18021971RESULT

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 14, 2005

Study Start

February 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

CH(1)