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Safety and Tolerability of Enteric-Coated Mycohenolate Sodium (EC-MPS) in Renal Transplant Patients with GI Intolerance - Article


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Nafcillin Sodium Injection

Nallpen; Unipen Injection


Clinical Trial: Safety and Tolerability of Enteric-Coated Mycohenolate Sodium (EC-MPS) in Renal Transplant Patients with GI Intolerance

This study is currently recruiting patients.
Verified by Novartis September 2005

Sponsors and Collaborators: Novartis
Not applicable
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00150020

Purpose

The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance renal transplant patients who experience GI intolerance due to adverse events associated with mycophenolate mofetil and were converted to EC-MPS.
Condition Intervention Phase
Renal Transplantation
 Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

Official Title: Safety and Tolerability of Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients with GI Intolerance

Further Study Details: 

Study start: October 2004

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  1. Males and females aged 18-75 years.
  2. Recipients of first or secondary cadaveric, living unrelated or living related kidney transplant.
  3. Recipients who are at least 4 weeks post renal transplantation.
  4. Patients currently receiving MMF (all dosages are allowed), cyclosporine microemulsion, its generic equivalent, Cyclosporine USP (modified) or Tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks.
  5. Patients with mild and/or moderate GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.
  6. Females of childbearing potential must have a negative pregnancy test prior to the inclusion period. The test should be performed at Baseline visit. If positive, the patient will not be included. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication.
  7. Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion Criteria:

  • 1. Multi-organ patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed).

    2. Evidence of graft rejection, treatment of acute rejection or unstable renal function within 4 weeks prior to Baseline visit.

    3. Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.

    4. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.

    5. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.

    6. Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<4,000/mm3), and/or hemoglobin <9.0 g/dL prior to enrollment.

    7. Presence of clinically significant infection requiring continued therapy, severe diarrhea or active peptic ulcer disease that would interfere with the appropriate conduct of the study.

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

    9. Patients who are HIV positive. 10. Abnormal physical or laboratory findings of clinical significance within 2 weeks of inclusion which would interfere with the objectives of the study.

    11. Patients with symptoms of significant somatic or mental illness. 12. Evidence of drug and/or alcohol abuse. 13. Inability to self-administer the GSRS and OTE questionnaire. Additional inclusion/ exclusion criteria may apply

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00150020

Novartis      1 862 778 8300 

New Jersey
      Novartis, East Hanover,  New Jersey,  United States; Recruiting
Novartis  862-778-8300 

Study chairs or principal investigators

Novartis,  Study Director,  Novartis   

More Information

Study ID Numbers:  CERL080AUS02
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00150020
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13


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Page Updated: June 1, 2005
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