NCT06466135 Study of WAL0921 in Patients With Glomerular Kidney Diseases
| NCT ID | NCT06466135 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Walden Biosciences |
| Condition | Diabetic Nephropathies |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2027-03 |
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 96 participants in total. It began in 2024-07-02 with a primary completion date of 2027-03.
⚠ 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 is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis \[FSGS\], treatment-resistant minimal change disease \[TR MCD\], primary immunoglobulin A nephropathy \[IgAN\], and primary membranous nephropathy \[PMN\]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.
Eligibility Criteria
Inclusion Criteria: * Adults, age 18-75 years * Diagnosis of one of the following glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment resistant-minimal change disease; primary IgA nephropathy; primary membranous nephropathy * eGFR greater than or equal to 30 mL/min/1.73 m2 Exclusion Criteria: * Currently pregnant or planning to become pregnant * History of organ transplantation * History of alcohol or substance use disorder * Acute dialysis or acute kidney injury within 6 months of Screening * Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements
Contact & Investigator
Andrew Blair, MD
STUDY DIRECTOR
Walden Biosciences
Frequently Asked Questions
Who can join the NCT06466135 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Diabetic Nephropathies. 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 NCT06466135 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 NCT06466135 currently recruiting?
Yes, NCT06466135 is actively recruiting participants. Contact the research team at clinicaltrials@waldenbiosciences.com for enrollment information.
Where is the NCT06466135 trial being conducted?
This trial is being conducted at Los Angeles, United States, Denver, United States, Tamarac, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT06466135 clinical trial?
NCT06466135 is sponsored by Walden Biosciences. The principal investigator is Andrew Blair, MD at Walden Biosciences. The trial plans to enroll 96 participants.