Effectiveness of Tacrolimus Azathioprine combination in comparison with Cyclophosphamide in SLE Nephropathy

Not Applicable

Completed

• Conditions: Health Condition 1: null- SLE with proliferative lupus nephritisHealth Condition 2: M321- Systemic lupus erythematosus withorgan or system involvement

• Registration Number: CTRI/2017/05/008556
• Lead Sponsor: West Bengal Government

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-02-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Patient with SLE as per ACR classification criteria with evidence of renal involvement with histopathological diagnosis of proliferative lupus nephritis as per ISN/RPS classification (Class III, IV, V+III and V+IV) and willing for regular treatment and follow-up.

2.Age >=18 years.

3.Completed induction therapy with any regimen before.

4.Willingness to continue on medications, follow-up and use contraceptive measures.

5.No contraindications to any of the maintenance regimen included in the study.

Exclusion Criteria

1.Patients with biopsy proven class IIIC/IV C.

2.Life threatening complication of Lupus (including specifically but not limited to cerebral lupus).

3.Contraindication to any of the therapy protocols or known hypersensitivity to treatment drugs.

4.Pregnancy or lactation.

5.Patients with advanced renal dysfunction (MDRD eGFR <30 ml/min/1.73m2)

6.Cases in which written informed consent is not available.

7.Patients with active life threatening infection/sepsis at onset, active viral hepatitis, HIV, any malignancy or any contraindication for immunosupression.

8.Renal Biopsy showing evidence of thrombotic microangiopathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified