A study to find out consequences of various treatment of lupus nephritis, which is a disease involving the kidneys ;information regarding the drugs and the amount of money spent by the patient for treatment.
- Conditions
- Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
- Registration Number
- CTRI/2020/02/023480
- Lead Sponsor
- Seth GS Medical College and KEM Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female patients, whose age is 16 and above ,attending Rheumatology clinic (OPD and IPD).
2. All classes of lupus nephritis diagnosed by ACR criteria, with proven renal biopsy ISN/RPS lupus nephritis.
3. Assent from patient and written informed consent from parent or guardian whose age is 16- <18 years.
4. Written informed consent for patients whose age is > 18 years.
1. Pregnant and lactating women.
2. Patients with lupus nephritis presenting with overlap syndrome and mixed connective tissue disorders. ( interfere with interpretation related to outcome of LN).
3. Critically ill patients of SLE with lupus nephritis requiring emergency management / admitted in ICU.
4. Co morbidities: Hypertension, diabetes, not controlled with medications. (interfere with clinical outcome assessment).
5. Patients diagnosed as tuberculosis, or hepatitis B, or hepatitis C (break in Rx or any severe systemic illness which will interfere with interpretation related to outcome of LN in the opinion of investigators.
6. Drug-induced lupus (Confounding factor).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To find out the clinical outcome in terms of disease activity in patients with lupus nephritis in Rheumatology clinic in a tertiary medical care hospital.Timepoint: Multiple time points (longitudinal study) and single time point cross sectional study(cross sectional study,18 months duration).
- Secondary Outcome Measures
Name Time Method 1. To study the prescription patterns in treatment of lupus nephritis <br/ ><br>2. To evaluate the Cost of treatment of lupus nephritis from Patientsâ?? Perspective. <br/ ><br>3. To assess the type, causality, severity and preventability of ADRs in lupus nephritis patients.Timepoint: Multiple time points