Health Condition 1: D898- Other specified disorders involving the immune mechanism, not elsewhere classified
Conditions
Interventions
Intervention1: Patients of SLE Class III/IV receiving MMF 2-3 g/d: AUC of MMF shall be determined and correlation will be established with efficacy and safety outcomes
Sponsors
INVESTIGATOR INITIATED TRIAL
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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 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. 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 3.To determine the correlation between AUC of MPA and incidence of adverse effects due to MMF in patients of Class III/IV LN | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 | — |
Countries
India
Contacts
Public ContactDr Smita Pattanaik
PGIMER, CHANDIGARH
Outcome results
None listed