Tests WAL0921 in people with kidney diseases that cause protein leakage
Tests WAL0921 or placebo in adults with glomerular kidney diseases and proteinuria.
Key facts
- Who runs it
- Walden Biosciences
- Where
- Bangalore, Bhubaneswar, Dehradun, Hyderabad, Jaipur, Kolkata, Lucknow, Meerut, Nadiād, New Delhi, Patparganj, Pune, Raipur, Sambhajinagar, and Vadodara, IndiaSee the 17 sitesAlso in 6 other countries, 33 sites
- Trial code
- Registry title
- Study of WAL0921 in Patients With Glomerular Kidney Diseases
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 96 people, planned
- Started
- 2 Jul 2024
- Expected to end
- Jun 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- WAL0921
- Placebo
- Record updated
- 3 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with a glomerular kidney disease (diabetic nephropathy, FSGS, treatment-resistant minimal change disease, IgA nephropathy or membranous nephropathy) and protein in the urine.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- One of these kidney diseases: diabetic nephropathy, primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary IgA nephropathy or primary membranous nephropathy. eGFR must be 30 mL/min/1.73 m2 or higher.
Main reasons for not taking part
- 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 condition that, in the investigator's judgment, would prevent safe participation
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- History of organ transplantation
- History of alcohol or substance use disorder
- Currently pregnant or planning to become pregnant
- Acute dialysis or acute kidney injury within 6 months of Screening
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in India
Also in 6 other countries, 33 sites
- Mazumdar Shah Medical CenterBangalore, IndiaContact: Michelle SkupienNo longer taking part
- MS Ramaiah Medical College and HospitalsBangalore, IndiaContact: Michelle SkupienNo longer taking part
- SUM HospitalBhubaneswar, IndiaContact: Michelle SkupienNo longer taking part
- Shri Guru Ram Rai Institute of Medical and Health SciencesDehradun, IndiaContact: Michelle SkupienNo longer taking part
- Nizam's Institute of Medical SciencesHyderabad, IndiaContact: Michelle SkupienNo longer taking part
- Osmania General HospitalHyderabad, IndiaContact: Michelle SkupienNo longer taking part
- SMS Medical College and HospitalJaipur, IndiaContact: Michelle SkupienNo longer taking part
- NRS Medical College and Hospital KolkataKolkata, IndiaContact: Michelle SkupienNo longer taking part
- Sanjay Gandhi Post Graduate Institute of Medical SciencesLucknow, IndiaContact: Michelle SkupienNo longer taking part
- Nutema HospitalMeerut, IndiaContact: Michelle SkupienNo longer taking part
- Muljibhai Patel Urological HospitalNadiād, IndiaContact: Michelle SkupienNo longer taking part
- Sir Ganga Ram HospitalNew Delhi, IndiaContact: Michelle SkupienNo longer taking part
- Max Super Speciality HospitalPatparganj, IndiaContact: Michelle SkupienNo longer taking part
- Manipal HospitalPune, IndiaContact: Michelle SkupienNo longer taking part
- AIIMS HospitalRaipur, IndiaContact: Michelle SkupienNo longer taking part
- MGM Medical Care and HospitalSambhajinagar, IndiaContact: Michelle SkupienNo longer taking part
- Dhiraj HospitalVadodara, IndiaContact: Michelle SkupienNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- WAL0921Treatment being tested
Intravenous infusion of investigational drug WAL0921
- PlaceboPlacebo, for comparison
Intravenous infusion of normal saline
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
- Plain-language title
- Tests WAL0921 in people with kidney diseases that cause protein leakageGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06466135, who can take part
- Record updated
- 3 August 2026