Efficacy and Safety of the Treatment of Primary Membranous Nephropathy: A Randomized Clinical Trial

NCT05532111 | Unknown DMC

• 1 other identifier: IIT-2021-0149
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Main purpose:
2. 2.Secondary research purposes:
3. 3.Exploratory research purposes:

Conditions

Efficacy and Safety

Keywords

Rituximab; Tacrolimus; Primary Membranous Nephropathy

Outcome Measures

Primary Outcomes (2)

• 24-hour urine protein quantification

  1. Remission: decreased proteinuria. Complete remission (CR): 24HUTP\<0.3g/L Partial remission (PR): 24HUTP decreased by \>50% and \>0.3g/L from baseline 2. Invalid: no decrease in proteinuria compared with baseline. 3. Recurrence: increased proteinuria (24-hour urine protein quantification ≥3.5g/d) , recurred after reaching CR or PR.

  48 weeks

• serum albumin

  1. Remission: serum albumin\>30g/L 2. Invalid: serum albumin \<30g/L 3. Recurrence: decreased serum albumin, \<30g/L, recurred after reaching CR or PR.

  48 weeks

Study Arms (3)

RT-R Group

EXPERIMENTAL

Rituximab combined with tacrolimus induction + rituximab maintenance

Drug: Rituximab combined with tacrolimus induction + rituximab maintenance

RT-T Group

EXPERIMENTAL

Rituximab combined with tacrolimus induction + tacrolimus maintenance

Drug: Rituximab combined with tacrolimus induction + tacrolimus maintenance

PC-C Group

EXPERIMENTAL

Glucocorticoid combined with cyclophosphamide induction + maintenance

Drug: Glucocorticoid combined with cyclophosphamide induction + maintenance

Interventions

Rituximab combined with tacrolimus induction + rituximab maintenance DRUG

RT-R group: Rituximab 1 g/time, once in 15 days, × 2 times, combined with tacrolimus, the initial dose is 0.05-0.1 mg/kg/d, 2 times at an interval of 12 hours, orally. Adjust the dose according to the blood concentration (maintain the blood concentration C0 4-8ng/ml). At the end of 24 weeks, tacrolimus was stopped, and rituximab was given 1 g/time × 1 time.

RT-R Group

Rituximab combined with tacrolimus induction + tacrolimus maintenance DRUG

RT-T group: Rituximab 1 g/time, once in 15 days, × 2 times, combined with tacrolimus, the initial dose is 0.05-0.1 mg/kg/d, 2 times at an interval of 12 hours, orally. Adjust the dose according to the blood concentration (maintain the blood concentration C0 4-8ng/ml).

RT-T Group

Glucocorticoid combined with cyclophosphamide induction + maintenance DRUG

PC-C group: The initial dose of prednisone/prednisolone was 0.5-1 mg/kg/d (the maximum dose was 70 mg/d), and the dose was gradually reduced after 4-8 weeks, and then stopped within 6-9 months. Cyclophosphamide 750mg/m2 (adjusted according to eGFR and other conditions), once a month, intravenous pulse therapy. CTX maintenance therapy.

PC-C Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• gender is not limited；
• Age 18-75；
• Kidney biopsy pathology suggests primary membranous nephropathy;
• Serological or histological PLA2R positive;
• hour urine protein quantification ≥3.5g/d and serum albumin \<30g/L;
• Glomerular filtration rate \[eGRF (CKD-EPI formula)\] ≥ 45ml/min/1.73m2;

You may not qualify if:

• Secondary membranous nephropathy (tumor-related, lupus-related, hepatitis B-related, infection-related, drug-related, etc.);
• Renal biopsy pathology showed severe tubulointerstitial lesions;
• Severe infection, severe cardiac insufficiency, severe hepatic insufficiency, gastrointestinal bleeding, ketoacidosis and other life-threatening complications within one month;
• Glucocorticoids and/or immunosuppressive therapy (cyclophosphamide, MMF, tacrolimus) within 3 months;
• Have a history of kidney transplantation;
• Breastfeeding or pregnant women;
• Patients with mental disorders or unable to cooperate ;

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Interventions

Maintenance

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Central Study Contacts

Qin Wang, doctor

CONTACT

+86136 2196 4604; qinwang_1975@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 8, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: September 8, 2022

Record last verified: 2022-09