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Randomized controlled trial for reduced cumulative immuno-suppression in the treatment of primary membranous nephropathy.

Standard versus low dose cyclical cyclophosphamide and steroids in the treatment of primary membranous nephropathy- a randomized controlled trial. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024880
Enrollment
50
Registered
2020-04-27
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: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis

Interventions

Intervention1: Low Dose cyclical cyclophosphamide and steroids regimen: oral prednisolone 0.5 mg/kg per day (OD) in the first, third, and fifth month and oral cyclophosphamide at 1-1.5 mg/kg per day (

Sponsors

Dr Manu Dogra
Lead Sponsor
Dr Rohit Tewari
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Either sex with biopsy proven primary MGN. 2. Persistent nephrotic syndrome despite non-immunosuppressive adjuvant treatment for 3 months or earlier due to complications requiring hospitalisation. 3. After informed and written consent.

Exclusion criteria

Exclusion criteria: 1. Patients with eGFR 2. Prior, active infection including hepatitis B/C and HIV infection 3. Positive for anti-nuclear factor 4. Monoclonal proteins in serum/urine 5. Any suggestion of malignancy on ultrasonography 6. Hypocomplementemia 7. Presence of tubular atrophy and interstitial fibrosis in >1/3rd biopsy area 8. Pre-existing DM 9. Abnormal liver function tests and secondary MN 10. Any immunosuppressive therapy in the last 12 months 11. Female of childbearing age who has a pregnancy plan, or is pregnant, or lactating.

Design outcomes

Primary

MeasureTime frame
Remission rates in both the groups at 12 months.Timepoint: Remission rates in both the groups at 12 months.—

Secondary

MeasureTime frame
(i) Number of patients with an increase â?¥ 50% creatinine from baseline at 12 and 18 months and at the end of follow-up. (ii) Time of renal survival at end of follow-up. (iii) Proportion of patients with preserved renal function after treatment period. (iv)Proportion of patients with relapse and the time to relapse. (v)Serum anti-PLA2R, before treatment and at 3, 6, 9, 12, 18 and 24 months of study, in both treatment arms. (vii)Tissue PLA2R staining by IHC at the baseline. Timepoint: 12 months, 18 months and 24 months—

Countries

India

Contacts

Public ContactDr Vivek Sood

Army Hospital (Research and Referral)

viverit@gmail.com8974321019

Outcome results

None listed

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