Health TrialsbyHealthPanel

A Study of SHR-2173 in Participants With Primary IgA Nephropathy

ConditionPrimary IgA Nephropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with Primary IgA Nephropathy(IgAN). The study consists of a screening period, a run-in period, a 48-week double-blind treatment period, and a 12-week follow-up period. Approximately 84 IgAN patients will be included.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female participants aged 18 or older

Body weight ≥35 kg, BMI<37.5 kg/m2

At screening, 24-hour urinary protein quantification ≥1 g/ day, or 24-hour UPCR≥0.7 g/g

eGFR≥30 mL/ minute /1.73 m2 at screening

Disqualifiers

Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary to systemic diseases, infections, autoimmune diseases or tumors;

A history of organ transplantation;

A history of splenectomy;

Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ with complete resection and no evidence of recurrence are excluded);

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-2173 injection

    Drug

    SHR-2173 injection；High dose

  • SHR-2173 injection

    Drug

    SHR-2173 injection；Medium dose

  • SHR-2173 injection

    Drug

    SHR-2173 injection；Low dose

  • Placebo

    Drug

    Placebo

Treatment groups

84 Participants
are divided into 4 treatment groups
Group A: Treatment group A: SHR-2173 injectionExperimental treatment 1 intervention
Group B: Treatment group B: SHR-2173 injectionExperimental treatment 1 intervention
Group C: Treatment group C: SHR-2173 injectionExperimental treatment 1 intervention
Group D: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in 24-hour Urine Protein-to-Creatinine Ratio (UPCR) at Week 24.

Time frame
Week 24.

Secondary outcomes

1

Change from baseline in 24-hour UPCR ;

Time frame
up to Week 48
2

Change from baseline in 24-hour Urinary Albumin-to-Creatinine Ratio (UACR) ;

Time frame
up to Week 48
3

Proportion of participants with 24-hour urinary protein quantification <0.5 g/d and <0.3 g/d ;

Time frame
up to Week 48
4

Proportion of participants with >30% and >50% reduction from baseline in 24-hour UPCR ;

Time frame
up to Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Hengrui Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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