Monitoring of Plasma Levels of Mycophenolate Mofetil (MMF) in Renal Transplant Recipients

Not Applicable

• Conditions: Health Condition 1: N186- End stage renal disease

• Registration Number: CTRI/2018/08/015214
• Lead Sponsor: Investigator initiated trial

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients who have undergone a de novo renal transplantation in the past two weeks (15 days) and have been started on MMF (CELLCEPT) at a dose of 1 g twice a day

2. Patients who have attained a steady state level of tacrolimus (10-15 ng/mL)

Exclusion Criteria

1.Patients who are started on enteric coated mycophenolate sodium (EC-MPS)

2.Patients who have previously undergone renal transplantation or any other solid organ transplantation

3.Patients suffering from infections such as HIV, Hepatitis B, Hepatitis C

4.Patients who are presently diagnosed to be suffering from any malignancy

5.Patients who are presently abusing of any narcotic or psychotropic drugs (marijuana, cocaine, opioids, amphetamines, barbiturates, benzodiazepines)

6.Patients found to have any gross abnormality in the general laboratory investigations at the time of screening

7.Patients with any chronic severe illness that is likely to jeopardize the conduct of study or interpretation of results, such as severe liver failure (MELD score >=30); severe heart failure (NYHA class IV) and severe chronic obstructive pulmonary disease (GOLD stage IV)

8.Women who are currently pregnant or nursing women or women who are in the reproductive age group and do not wish to use any method of contraception

9.Patients who have participated in any clinical trial or have received any investigational new drug in the past 6 months

10.Patients not willing to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the difference between AUC controlled-dose adjustment and clinical judgement based-dose adjustment of MMF in the first six months after de novo renal transplantation in terms of <br/ ><br>1. incidence of biopsy proven acute graft rejection <br/ ><br> <br/ ><br>2. incidence of gastrointestinal adverse events <br/ ><br> <br/ ><br>3. overall treatment expenditure <br/ ><br> <br/ ><br>4. quality of life on the EQ-5D-5L questionnaire <br/ ><br>Timepoint: First six months after renal transplantation

Secondary Outcome Measures

Name	Time	Method
1.To determine any association between AUC of MMF and the biopsy proven acute graft rejection in the first 6 months after de novo renal transplantation <br/ ><br>2.To determine any association between AUC of MMF and the incidence of gastrointestinal adverse effects in the first 6 months after de novo renal transplantation <br/ ><br>3. To determine the difference between AUC controlled-dose adjustment and clinical judgement based-dose adjustment in terms of severity of gastrointestinal adverse events <br/ ><br> <br/ ><br>Timepoint: First six months after de novo renal transplantation