A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 6 entries
    • Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 16 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
This is a Phase I trial designed to evaluate the impact of renal impairment on the efficacy and safety of the drug by comparing pharmacokinetic (PK) parameters and pharmacodynamic (PD) markers after a single subcutaneous injection of RG002C0106 between trial participants with normal renal function and those with mild to moderate renal impairment.
Trial Details
NCT Number NCT07445906
Lead Sponsor Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
Conditions
(from sponsor)		 Renal Impairments, IgA Nephropathy (IgAN)
Related terms Glomerulonephritis, IGA
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov