Not Yet RecruitingPhase 3

Efficacy and Safety of Tacrolimus in Combination With Ripertamab in the Initial Treatment of Patients With MCD

81 participantsStarted 2024-05

Plain-language summary

To evaluate the safety and efficacy of ripertamab and its combination with tacrolimus in the initial treatment of MCD to provide a treatment regimen with higher remission rates, lower recurrence rates, and fewer side effects in patients with MCD.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age 18-80 years old;
✓. Primary minimal change disease confirmed by renal biopsy (Initial therapy);
✓. 24h-UTP\>3.5g/d or PCR\>3500mg/g, and serum albumin\<30g/L;
✓. Agree to participate in the project and sign the informed consent.

Exclusion criteria

✕. Secondary minimal change disease;
✕. eGFR\<60 mL/min/1.73m2;
✕. Had history of mental disease, dysnoesia, serious cardiovascular and cerebrovascular diseases, pulmonary insufficiency, malignant tumors or other major diseases that are not suitable for clinical experiments;
✕. Active bleeding in the gastrointestinal tract;
✕. Prior treatment with corticosteroids or other immunosuppressants;
✕. HBV, HCV, HIV or other untreated infections, congenital or acquired immunodeficiency diseases;
✕. Have been vaccinated with live vaccine in the past four weeks;
✕. Serum bilirubin \> 3.6mg/dl for at least 1 month or liver function ≥3 times the upper limit of normal value;

What they're measuring

Relapse rate at 24 months

Timeframe: Up to 24 months after enrollment

Trial details

NCT IDNCT06405100

SponsorAir Force Military Medical University, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04

Contact for this trial

shiren Sun[Author], Doctor

18729387675 272844142@qq.com

View on ClinicalTrials.gov More Minimal Change Disease trials