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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00646737
Other study ID # CERL080ABR02
Secondary ID
Status Completed
Phase Phase 4
First received March 18, 2008
Last updated February 21, 2017
Start date May 2008
Est. completion date December 2008

Study information

Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mycophenolate sodium
Mycophenolate sodium

Locations

Country Name City State
Brazil Novartis Investigative Site Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Brazil, 

References & 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 Bra — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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