NCT06989359 Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
| NCT ID | NCT06989359 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | ADARx Pharmaceuticals, Inc. |
| Condition | IgAN |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-08-28 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2025-08-28 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.
Eligibility Criteria
Inclusion Criteria: * Mean eGFR greater than or equal to 30 mL/min/1.73m2 * Clinical evidence of active kidney disease * Treated with supportive care including an ACE inhibitor or ARB if applicable * Willing to receive required vaccinations * Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy Exclusion Criteria: * Hereditary or acquired complement deficiency * Kidney transplant or renal replacement therapy * History of solid organ transplant * Other kidney disease * History of recurrent invasive infections * Received complement inhibitor treatments * Active systemic viral, bacterial, or fungal infection * Abnormal liver function
Contact & Investigator
Arezoo Mirad, MD
STUDY DIRECTOR
ADARx Pharmaceuticals, Inc.
Frequently Asked Questions
Who can join the NCT06989359 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying IgAN. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06989359 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06989359 currently recruiting?
Yes, NCT06989359 is actively recruiting participants. Contact the research team at info@adarx.com for enrollment information.
Where is the NCT06989359 trial being conducted?
This trial is being conducted at Doral, United States, Miami, United States, Pembroke Pines, United States, Iowa City, United States and 11 additional locations.
Who is sponsoring the NCT06989359 clinical trial?
NCT06989359 is sponsored by ADARx Pharmaceuticals, Inc.. The principal investigator is Arezoo Mirad, MD at ADARx Pharmaceuticals, Inc.. The trial plans to enroll 45 participants.