Does plasma level of mycophenolate mofetil affect its effects produced in patients with Lupus Nephritis?

Not Applicable

Conditions: Health Condition 1: D898- Other specified disorders involving the immune mechanism, not elsewhere classified

Registration Number: CTRI/2018/08/015219

Lead Sponsor: INVESTIGATOR INITIATED TRIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Participants above 18 years of age of either sex

2.Participants fulfilling any 4 of the ACR criteria for SLE

3.Participants diagnosed as Class III or Class IV lupus nephritis according to the ISN/RPS classification of lupus nephritis, 2003 on the basis of renal biopsy

4.Participants receiving MMF (CELLCEPT) at doses of 2-3 g/day

Exclusion Criteria

1.Participants receiving enteric coated mycophenolate preparations (EC-MPS or MYFORTIC)

2.Participants suffering from SLE but no renal involvement or renal involvement of ISN/RPS class I/II/V/VI

3.Participants suffering from any malignancy requiring surgery, ongoing chemotherapy or radiation

4.Participants suffering from any active infection at the time of enrolment

5.Participants who have received any investigational drug in the past 6 months

6.Pregnant, nursing mothers or women of childbearing potential who are not willing to use an efficient method of birth control

7.Participants with a past history of hypersensitivity to MMF

8.Participants with any gross abnormality on the baseline investigations

9.Participants not willing to provide written informed consent

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To estimate the plasma concentration of MPA in Class III/IV LN patients in steady-state of MMF therapy at 1h, 2h and 6h after a dose of the drug. <br/ ><br>2.To determine the correlation between AUC of MPA and reduction of proteinuria to less than 0.3g per 24 hour and and clearance of casts in urine in Class III/IV LN patients <br/ ><br>3.To determine the correlation between AUC of MPA and incidence of adverse effects due to MMF in patients of Class III/IV LNTimepoint: 1.To estimate the plasma concentration of MPA in Class III/IV LN patients in steady-state of MMF therapy at 1h, 2h and 6h after a dose of the drug. <br/ ><br>2.To determine the correlation between AUC of MPA and reduction of proteinuria to less than 0.3g per 24 hour and and clearance of casts in urine in Class III/IV LN patients <br/ ><br>3.To determine the correlation between AUC of MPA and incidence of adverse effects due to MMF in patients of Class III/IV

Secondary Outcome Measures

Name	Time	Method
1.To divide the patients of lupus nephritis into AUC less than 30 mg.h/L, 30-60 mg.h/L and more than 60 mg.h/L and correlate with induction of disease remission <br/ ><br>2.To divide the patients of lupus nephritis into AUC less than 30 mg.h/L, 30-60 mg.h/L and more than 60 mg.h/L and correlate with maintenance of disease remissionTimepoint: First six months of induction therapy