Rituximab and Tacrolimus drugs in primary membranous nephropathy

Not yet recruiting

Brief Summary: **Aims and Objectives ofthe Study:**

**Aim:** To compare the safety and efficacy of intravenousrituximab with tacrolimus in the management of primary membranous nephropathy

**Objectives:**

â€¢      Compare the efficacy ofrituximab and tacrolimus in achievement of remission in primary membranous nephropathy.

â€¢      Compare the percentageof change of proteinuria in response to rituximab and tacrolimus.

â€¢      Compare the side effectprofile and tolerability of rituximaband tacrolimus in primary membranousnephropathy.

**Materials and Methods:**

**Study Area:** The study will be a single center studyto be conducted in the Department of Nephrology, IPGME& R and SSKMHospital.

**Study design:**This willbe a Prospective open label randomized parallel group interventional study

**Method of randomization**: Random number table

**Studypopulation**:   All primarymembranous nephropathy patients admitted in the Department of Nephrology, those attending OPD services andthose referred to this department from other hospitals will constitute thestudy population.

Recruitment & Eligibility

Inclusion Criteria

1.Biopsy proven PMN of age group 18-70 years, 2.Fulfilling the criteria for initiation of immunosuppression- Urinary protein excretion persistently exceeds4 g/d AND remains at over 50% of the baseline value, AND does not show progressive decline, during antihypertensive and antiproteinuric therapy during an observation period of at least 6 months or Severe disabling or life threatening symptoms related to the nephrotic syndrome.
3.SCr has risen by 30% or more within 6 to 12 months from the time of diagnosis but the eGFR is not less than 25â€“30 ml/min per 1.73m2 AND this change is not explained by superimposed complications.

Exclusion Criteria

1.Patients with active infection.
2.Diabetes mellitus.
3.Hepatitis B/C or human immunodeficiency virus infection.
4.Superimposed any other liver disease.
5.Neoplasia.
6.Chronic Diarrhoea.
7.Pregnancy.
8.Patients not willing for contraception.
9.Previous therapy with Prednisolone, MMF,CSA within 4 months and alkylating agents within 6 months.

Primary Outcome Measures

Name	Time	Method
The number of patients who will experience remission both partial and complete remission on the basis of urine protein analysis.	The duration of follow-up will be at least 6 month

Secondary Outcome Measures

Name	Time	Method
a)Estimated glomerular filtration rate (eGFR) at the completion of therapy	b)Change in 24 hour urinary protein

Locations (1): IPGMER, SSKM hospital
🇮🇳
Kolkata, WEST BENGAL, India
IPGMER, SSKM hospital
🇮🇳Kolkata, WEST BENGAL, India
Aneesh Nanda
Principal investigator
8728951509
aneeshnanda@hotmail.com