Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant

• ClinicalTrials.gov Identifier: NCT00646737
• Recruitment Status: Completed
• First Posted: March 28, 2008
• Last Update Posted: February 23, 2017
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Study Description

Brief Summary:

The purpose of this study is to evaluate the safety and the tolerability of the substitution of mycophenolate mofetil for enteric-coated mycophenolate sodium in a population of stable renal transplant patients in Brazil, in a treatment regimen of immunosuppressants with tacrolimus and mycophenolate mofetil.

Condition or disease	Intervention/treatment	Phase
Kidney Transplantation	Drug: Mycophenolate sodium	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase IV Study of Enteric-coated Mycophenolate Sodium in Combination With Tacrolimus in Renal Transplant Patient
• Study Start Date: May 2008
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Mycophenolate sodium	Drug: Mycophenolate sodium; Mycophenolate sodium

Outcome Measures

Primary Outcome Measures :

1. Gastrointestinal symptoms in renal transplant patients treated with the immunosuppression regimen of tacrolimus and mycophenolate at baseline, 8 and 16 weeks [ Time Frame: 8 and 16 weeks ]

Secondary Outcome Measures :

1. Impact of gastrointestinal symptoms on quality of life. Tolerability of mycophenolate sodium in combination with tacrolimus assessed by OSRS. Safety of mycophenolate sodium in combination with tacrolimus assessed by incidence of adverse events [ Time Frame: 8 and 16 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria

• Age between 18 and 65 years;
• First or second renal transplant within at least 12 weeks;
• Clinical stability, in the opinion of the investigator, during at least 8 weeks before inclusion in the study;
• Women of reproductive age must use contraceptive methods and present negative results in pregnancy test Serum creatinine < 2.5 mg/dE; Patients in use of a immunosuppression regimen based on tacrolimus and mycophenolate mofetil (generic or not, in any dose), who present gastrointestinal symptoms Capacity to complete the study requirements;

Exclusion criteria History of acute rejection,

• Proven or not by biopsy, in the last 2 months before the study;
• Recipients of multiple organs;
• Participation in any clinical investigation in the last 6 months before the present study;
• Thrombocytopenia (platelets <75,00O/mm3), leucopenia (total leukocytes <4,000/mm3)and/or anemia (hemoglobin <9.0 gldL) before inclusion in the study;
• Clinically important disease, in the opinion of the investigator, including systemic infection, within 2 weeks before inclusion in the study;
• Presence of any neoplasia, current or past, except resected basal cell carcinoma;
• Any surgical or medical condition that could significantly alter the absorption, distribution, metabolism or excretion of medicines or that could put the patient in danger as a result of participation in the study;
• History of drug or alcohol abuse within previous 12 months of inclusion in the study, Current or prior use in the last 2 months of bile acid-adsorbing resins(cholestyramine and colestipol).

Contacts and Locations

Locations

Brazil

Novartis Investigative Site

Sao Paulo, Brazil

Sponsors and Collaborators

Novartis

Investigators

• Study Director: Novartis; Novartis

More Information

Publications of Results:

Pacheco e Silva Filho A, Manfro RC, Contieri FL, Mazzali M, Garcia VD, Carvalho Dde B, David S, Machado P, Rodrigues CA. Evaluation of tolerability of enteric-coated mycophenolate sodium versus mycophenolate mofetil in de novo renal transplantation. J Bras Nefrol. 2015 Jul-Sep;37(3):291-6. doi: 10.5935/0101-2800.20150048. English, Portuguese.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00646737
• Other Study ID Numbers: CERL080ABR02
• First Posted: March 28, 2008
• Last Update Posted: February 23, 2017
• Last Verified: February 2017

Keywords provided by Novartis:

Kidney transplantation; conversion; mycophenolate mofetil; mycophenolate sodium,; tacrolimus

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