96 Participants Needed

WAL0921 for Kidney Disease

Recruiting at 8 trial locations
MS
Overseen ByMichelle Skupien
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Walden Biosciences
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, WAL0921, for individuals with certain kidney diseases that cause high protein levels in the urine, including diabetic kidney disease and some rare kidney conditions. The trial aims to determine if WAL0921 is safe and effective in reducing these protein levels compared to a placebo (a substance with no active medication). Participants will receive an infusion every two weeks for 14 weeks and will be monitored for 24 weeks after treatment ends. This trial may suit those diagnosed with diabetic nephropathy or specific rare kidney diseases who have not recently required dialysis. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that WAL0921 is likely to be safe for humans?

Research has shown that WAL0921 is safe and generally well-tolerated by patients. In earlier studies, participants handled the treatment well, and researchers found no major safety issues. WAL0921 also effectively lowered certain proteins linked to kidney inflammation. While every treatment carries some risk, current evidence suggests that WAL0921 is a promising option for people with kidney diseases.12345

Why do researchers think this study treatment might be promising for kidney disease?

Researchers are excited about WAL0921 for kidney disease because it offers a novel approach compared to standard treatments like ACE inhibitors and ARBs. Unlike these traditional therapies, WAL0921 is administered intravenously, which could mean more precise delivery and potentially faster action. Additionally, WAL0921 may work through a different mechanism, offering hope for patients who do not respond well to current oral medications. This fresh angle not only holds promise for increased effectiveness but also expands treatment options for those with challenging cases of kidney disease.

What evidence suggests that WAL0921 might be an effective treatment for kidney disease?

Research has shown that WAL0921, which participants in this trial may receive, holds promise for treating kidney diseases. Studies have found that it effectively lowers suPAR, a protein linked to kidney inflammation and damage. By reducing suPAR levels, WAL0921 may help decrease excess protein in urine, a sign of kidney disease. Initial findings suggested that WAL0921 is safe and well-tolerated in patients. These results are encouraging for people with conditions like diabetic kidney disease and rare kidney disorders.13456

Who Is on the Research Team?

AB

Andrew Blair, MD

Principal Investigator

Walden Biosciences

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • WAL0921
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: WAL0921Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Walden Biosciences

Lead Sponsor

Trials
2
Recruited
140+

Citations

Study of WAL0921 in Patients With Glomerular Kidney ...This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and ...
Walden Biosciences Fully Enrolls First Cohort in Phase 2 ...It has completed initial dosing of all subjects in the first cohort of a Phase 2 basket study evaluating WAL0921 as a treatment for chronic kidney diseases.
Walden Biosciences Completes Enrollment for Phase 2 ...The results demonstrated that WAL0921 was safe, well-tolerated, and effective in rapidly reducing free suPAR levels in a dose-dependent manner.
SuPAR And Kidney InflammationInitial data with WAL0921 demonstrated that it is safe and effective in reducing the levels of suPAR. “WAL0921 is designed to directly target ...
Walden WAL0921-02 Study Denver, COSafety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients with Glomerular Kidney Diseases and Proteinuria. This field is hidden when ...
Walden Biosciences Announces Positive Topline Data ...Data from the study showed that WAL0921 was safe, well-tolerated, and demonstrated proof-of-biology through a rapid, dose-dependent reduction in free suPAR ...
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