The effect of glucocorticoid withdrawal on maintenance therapy for lupus nephritis ---- Prospective single-center randomized controlled clinical study

The effect of glucocorticoid withdrawal on maintenance therapy for lupus nephritis--a prospective single-center randomized controlled clinical study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500100157

Enrollment

Unknown

Registered

2025-04-03

Start date

2020-12-12

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

lupus nephritis

Interventions

glucocorticosteroid withdrawal group:Subjects were tapered off hormones over 3 months and given maintenance immunosuppressive maintenance therapy alone (AZA, MMF, FK506, MMF+FK506, TW, LEF, etc.).

glucocorticosteroid maintenance group:Prednisone (5-10 mg/d) or equivalent glucocorticoids combined with maintenance immunosuppressant (AZA, MMF, FK506, MMF+FK506, TW, LEF, etc.) therapy.

Eligibility

Sex/Gender

All

Age

14 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. signed written informed consent; 2. Patients' age 14-70 years (including 14 and 70 years), gender is not limited; 3. meet the diagnostic criteria of ACR regarding SLE; LN is clearly diagnosed by renal biopsy, and the pathological type manifestation meets the ISN/RPS 2003 staging criteria: type II (excluding lupus podocytosis), type III, type IV, type V, or type III+V, type IV+V; 4. Patients who have achieved remission into maintenance therapy by induction therapy and have received stable immunosuppressive maintenance therapy for >=1 year;

Exclusion criteria

Exclusion criteria: 1. the presence of severe extra-renal complications; 2. patients expected to enter renal replacement therapy within 1 year; 3. abnormal liver function (aspartate transferase, alanine transferase, or total bilirubin greater than 2.5 times the upper limit of normal) within 1 month prior to randomization; 4. chronic obstructive pulmonary disease requiring long-term oral hormone therapy for asthma; 5. Co-existing autoimmune diseases that may affect the evaluation or outcome of the study; 6. Patients with poor study compliance or inability to cooperate with treatment; 7. conditions considered by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

Measure	Time frame
serum creatinine;Proteinuia;complement C3;complement C4;dsDNA titer;Arrival time of flare;	—

Countries

China

Contacts

Public ContactZHANG Haitao

General Hospital of Eastern Theater Command

htzhang163@163.com+86 139 5195 3690

Outcome results

None listed

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