WAL0921 for Kidney Disease

Recruiting at 3 trial locations

Overseen By Michelle Skupien

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Walden Biosciences

Disqualifiers: Pregnancy, Organ transplant, Substance use, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research Team

Andrew Blair, MD

Principal Investigator

Walden Biosciences

Eligibility Criteria

Adults aged 18-65 with certain kidney diseases (like diabetic nephropathy, primary FSGS, resistant minimal change disease, IgA nephropathy, or membranous nephropathy) and a minimum eGFR of 30 mL/min/1.73 m2 can join this study.

Inclusion Criteria

I have been diagnosed with a specific kidney disease.

My kidney function is normal or mildly reduced.

I am between 18 and 65 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions

14 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Treatment Details

Interventions

• WAL0921 (Other)

Trial Overview The trial is testing WAL0921 against a placebo in patients with glomerular kidney diseases. Participants will receive the drug or placebo via IV every two weeks for seven doses and be monitored for six months after the last dose.

Participant Groups

Group I: WAL0921 Experimental Treatment 1 Intervention

Intravenous infusion of investigational drug WAL0921

Group II: Placebo Placebo Group 1 Intervention

Intravenous infusion of normal saline

Who Is Running the Clinical Trial?

Walden Biosciences

Lead Sponsor

Trials

2

Recruited

140+