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A study compares the effectiveness and side effect of two drug named rituximab and tacrolimus in minimal change disease and Focal Segmental Glomerulosclerosis where steroid do not work

Open Label Randomized Control Trial Comparing Tacrolimus And Rituximab In Adult Onset Steroid Resistant Focal Segmental Glomerulosclerosis And Minimal Change Disease

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011316
Enrollment
20
Registered
2018-01-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- adult steroid resistant FSGS and MCD

Interventions

Intervention1: Tacrolimus: Arm-I will receive tacrolimus at the dose of 0.075 mg/kg body weight. Dose adjusted to maintain tacrolimus trough level 5-10 ng/ml Control Intervention1: Rituximab: Arm-II w

Sponsors

Institute of Post Graduate Medical Education and Research Seth Sukhlal Karnani Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient of age within 18-60 year. 2. Biopsy proven minimal change disease and focal segmental glomerulosclerosis 3. Receive 16 week of oral prednisolone in adequate dose without remission. 4. Estimated glomerular filtration (by MDRD) >30 ml/min/1.73m2 BSA 5. Tubular atrophy and fibrosis 6. Patient receiving maximum tolerable dose of antiproteinuric medication. 7. Patient willing to give consent for the study 8. No contraindication to any of the medication used in the study

Exclusion criteria

Exclusion criteria: 1. Patients with active infection 2. Diabetes mellitus 3. Hepatitis B/C or human immunodeficiency virus infection 4. Liver function abnormalities, 5. Neoplasia 6. Chronic Diarrhoea 7. Pregnancy 8. Secondary FSGS 9. Collapsing variant of FSGS 10. Previous therapy with MMF, azathioprine, cyclophosphamide and CSA 11. More than one episode of serious infections (e.g.,peritonitis, lower respiratory infection, cellulitis) in the past 12 months, current or previous therapy for tuberculosis.

Design outcomes

Primary

MeasureTime frame
the cumulative number of patients who will experience remission both partial and complete remissionTimepoint: 1 month 2 month 3 month 6 month 9 month and 12 month—

Secondary

MeasureTime frame
a) Estimated glomerular filtration rate (eGFR) at the completion of therapy b) Doubling of baseline serum creatinine levels (increase by 100%) c) Time will require for complete or partial remission d) Adverse effects (tremors, nephrotoxicity, gum hypertrophy, impaired glucose tolerance (IGT)/diabetes mellitus, diarrhoea and impaired fasting lipid profile, infection). Timepoint: 1year—

Countries

India

Contacts

Public ContactRajib Mondal

IPGMER and SSKM hospital

deepsircar@gmail.com9433407355

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026