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Comparison of 2 steroid tapering protocol in adult minimal change disease.

Steroid Tapering Protocol in Adult nephrotic syndrome due to MCD- A Randomised Control Trial of 2 regimens - MCD

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/12/006439
Enrollment
188
Registered
2015-12-16
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 minimal change disease

Interventions

Intervention1: Steroids Taper over 2 months.: After achievement of remission with 1 mg/kg of oral Prednisolone, the drug will be tapered to stop over a period of 2 months. Control Intervention1: Ste

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Nephrotic syndrome 2. Biopsy proved minimal change disease

Exclusion criteria

Exclusion criteria: 1. Hepatitis B, C or human immunodeficiency virus-I/II infection 2. Prior use of steroids/ immunosuppressive medication for any indication. 3. Persistent renal dysfunction even after remission of proteinuria 4. Nephrotic syndrome requiring >8 weeks to achieve remission 5. History of Diabetes mellitus (DM) 6. Abnormal liver function tests 7. Presence of active sediments in the urine defined as > 5 RBCs/ HPF in unspun urine 8. Anti nuclear antibody positivity 9. Drug induced MCD (Analgesic or omeprazole induced)

Design outcomes

Primary

MeasureTime frame
Time to first relapse.Timepoint: Time to first relapse.

Secondary

MeasureTime frame
Number of relapses, total prednisolone dose, adverse events: episodes of upper/lower respiratory tract infection, diabetes mellitusTimepoint: 6 and 12 months

Countries

India

Contacts

Public ContactRaja Ramachandran

PGIMER

drraja_1980@yahoo.co.in9216958874

Outcome results

None listed

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