Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium After Equimolar Conversion From Mycophenolate Mofetil (MMF) in Patients With Renal Transplant
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ClinicalTrials.gov Identifier: NCT00171379 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Last Update Posted
: February 2, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prevention of Acute Rejection After Kidney Transplantation | Drug: Enteric-Coated Mycophenolate Sodium | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 162 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Patients With Renal Transplant |
Study Start Date : | March 2004 |
Actual Primary Completion Date : | June 2005 |
Actual Study Completion Date : | June 2005 |

- Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula
- Incidence of biopsy proven acute rejection
- Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)
- Quality of life related to GI symptoms (GIQLI scale)
- Full blood count
- Gastrointestinal Adverse Events (check-list)

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
-
First or second (single or double) deceased or living donor kidney transplant received at least six months previously;
- Immunosuppressive therapy with cyclosporin and mycophenolate mofetil (MMF);
- Receiving an MMF dose of <2/g/day because of any adverse event and/or altered laboratory test result attributed to MMF
Exclusion Criteria:
-
• Subjects expected to discontinue cyclosporin therapy;
- Patients with thrombocytopenia (<75,000/mm3), an absolute neutrophil count of <1,500/mm3 and/or leukopenia (<2,500/mm3), or anemia (hemoglobin <6 g/dl) at baseline;
- Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia >2.5 mg/dL) or worsening renal function in the previous two months.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171379
Study Director: | Novartis | Novartis |
Responsible Party: | Novartis External Affairs, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00171379 History of Changes |
Other Study ID Numbers: |
CERL080AIT01 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | February 2, 2011 |
Last Verified: | February 2011 |
Keywords provided by Novartis:
Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium. |
Additional relevant MeSH terms:
Mycophenolic Acid Antibiotics, Antineoplastic Antineoplastic Agents Antibiotics, Antitubercular Antitubercular Agents |
Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |