Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant

NCT00646737 | Completed Phase 4

• 1 other identifier: CERL080ABR02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal symptoms in renal transplant patients treated with the immunosuppression regimen of tacrolimus and mycophenolate at baseline, 8 and 16 weeks

  8 and 16 weeks

Secondary Outcomes (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

  8 and 16 weeks

Study Arms (1)

1

EXPERIMENTAL

Mycophenolate sodium

Drug: Mycophenolate sodium

Interventions

Mycophenolate sodium DRUG

Mycophenolate sodium

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years;
• First or second renal transplant within at least 12 weeks;
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site

São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 26398638 RESULT

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 28, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

BR (1)