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Effect of GSTP1 polymorphism in Lupus nephropathy patients on cyclophosphamide aggressive therapy

Effect of GSTP1 polymorphism in Lupus nephropathy patients on cyclophosphamide aggressive therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180828012
Enrollment
Unknown
Registered
2018-08-28
Start date
2016-01-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Systemic Lupus erythematosus nephropathy Cyclophosphamide therapy&#44

Interventions

1 mg/ kg/ day is taken daily for 4 weeks. The dose of IV CYC 10 mg/kg is approximately 0.4 g/m2. At consolidation phase of five months&#44
monthly IV CYC dose was also 10 mg/kg (not more than 400 mg/ month) and monthly IV MP was 250 mg. ,The dose of CYC given in this guideline for induction therapy was IV CYC &#45
monthly IV CYC dose was also 10 mg/kg (not more than 400 mg/ month) and monthly IV MP was 250 mg.
Active Comparator Drug,Experimental Drug
cyclophosphamide aggressive therapy (GSTP1 &#45
wild type),cyclophosphamide aggressive therapy (GSTP1 &#45
polymorphism)
The dose of CYC given in this guideline for induction therapy was IV CYC &#45
600 mg [10 mg/kg/ mth] (not more than 600 mg)] in 1 day and the dose of corticosteroid was IV methyl prednisolone (MP) &#45
500 mg for 3 Days and PO Prednisolone&#45

Sponsors

Self
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: SLE nephropathy patients who were admitted to the Rheumatology ward, 500 bedded Yangon Specialty Hospital to treat with IV cyclophosphamide aggressive therapy. All the patients were treated according to the YSH guideline of aggressive therapy for renal involvement. Patients of all ages, both sex and who gave informed consent were included in the study.

Exclusion criteria

Exclusion criteria: Patients with Serum creatinine >300 µmol/L and relapses cases were excluded from the present study.

Design outcomes

Primary

MeasureTime frame
GSTP1 polymorphism after recuritment PCR-RFLP,Response or remission baseline, after 3rd and last cycle of Cyclophosphamide 24 hour urinary protein,urine analysis (RBC, leucocytes, cellular cast)—

Secondary

MeasureTime frame
Side effects of Cyclophosphamide (Myelosupression) at base line, at 10th day after the start of induction phase or after monthly consolidation phase fo Blood for complete picture—

Countries

Myanmar

Contacts

Public ContactK Khine Thu

Department of Pharmacology, University of Medicine 1, Yangon

drkkt2011@gmail.com+9595152408

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026