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New treatment option for Diabetic Nephropathies
Official title Study of WAL0921 in Patients With Glomerular Kidney Diseases
ClinicalTrials.gov ID: NCT06466135
What this study is testing
What is WAL0921?
WAL0921 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diabetic nephropathies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Adults, age 18-75 years
- Diagnosis of one of the following glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment...
- eGFR greater than or equal to 30 mL/min/1.73 m2
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Denver, Colorado, United States
- Tamarac, Florida, United States
- Atlanta, Georgia, United States
- Hinsdale, Illinois, United States
- Dakota Dunes, South Dakota, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Westmead, New South Wales, Australia
- St Albans, Victoria, Australia
- Raipur, Chhattisgarh, India
- Nadiād, Gujarat, India
- Vadodara, Gujarat, India
- Bangalore, Karnataka, India
- Pune, Maharashtra, India
- Sambhajinagar, Maharashtra, India
- New Delhi, National Capital Territory of Delhi, India
- Patparganj, National Capital Territory of Delhi, India
- Bhubaneswar, Odisha, India
- Jaipur, Rajasthan, India
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Denver, Colorado, United States; Tamarac, Florida, United States; Atlanta, Georgia, United States; Hinsdale, Illinois, United States; Dakota Dunes, South Dakota, United States and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.