Diabetic NephropathiesPhase 2NCT06466135
Study of WAL0921 in Patients With Glomerular Kidney Diseases
A Phase 2 study testing WAL0921 in people with Diabetic Nephropathies and Primary Focal Segmental Glomerulosclerosis, run by Walden Biosciences at 50 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathies, Primary Focal Segmental Glomerulosclerosis, Minimal Change Disease
- What is being tested?
- WAL0921
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 50 sitesin 7 countries
- Study dates
- 2 Jul 2024to Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
50 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
50 sites in 7 countries
India17 sites
- Active, not recruiting
MS Ramaiah Medical College and Hospitals
Bangalore, Karnataka, 560054
- Active, not recruiting
Mazumdar Shah Medical Center
Bangalore, Karnataka, 560099
- Active, not recruiting
SUM Hospital
Bhubaneswar, Odisha, 751029
- Active, not recruiting
Shri Guru Ram Rai Institute of Medical and Health Sciences
Dehradun, Uttarakhand, 248001
- Active, not recruiting
Osmania General Hospital
Hyderabad, Telangana, 500012
- Active, not recruiting
Nizam's Institute of Medical Sciences
Hyderabad, Telangana, 500082
- Active, not recruiting
SMS Medical College and Hospital
Jaipur, Rajasthan, 302004
- Active, not recruiting
NRS Medical College and Hospital Kolkata
Kolkata, West Bengal, 700014
- Active, not recruiting
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014
- Active, not recruiting
Nutema Hospital
Meerut, Uttar Pradesh, 250002
- Active, not recruiting
Muljibhai Patel Urological Hospital
Nadiād, Gujarat, 387003
- Active, not recruiting
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
- Active, not recruiting
Max Super Speciality Hospital
Patparganj, National Capital Territory of Delhi, 110092
- Active, not recruiting
Manipal Hospital
Pune, Maharashtra, 411045
- Active, not recruiting
AIIMS Hospital
Raipur, Chhattisgarh, 492099
- Active, not recruiting
MGM Medical Care and Hospital
Sambhajinagar, Maharashtra, 431003
- Active, not recruiting
Dhiraj Hospital
Vadodara, Gujarat, 391760
United States9 sites, 9 recruiting
- Recruiting
Fides Clinical Research
Atlanta, Georgia, 30342
- Recruiting
Dunes Clinical Research
Dakota Dunes, South Dakota, 57049
- Recruiting
Colorado Kidney and Vascular Care
Denver, Colorado, 80012
- Recruiting
Nephrology Associates of Northern Illinois and Indiana (NANI)
Hinsdale, Illinois, 60521
- Recruiting
Prolato Clinical Research Center
Houston, Texas, 77054
- Recruiting
Clinical Trial Network
Houston, Texas, 77074
- Recruiting
Academic Medical Research Institute
Los Angeles, California, 90022
- Recruiting
Clinical Advancement Center
San Antonio, Texas, 78212
- Recruiting
D & H Tamarac Research Center
Tamarac, Florida, 33321
Malaysia6 sites, 6 recruiting
- Recruiting
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000
- Recruiting
Hospital Sultan Idris Shah Serdang
Kajang, Selangor, 43000
- Recruiting
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 50603
- Recruiting
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100
- Recruiting
Sunway Medical Centre
Petaling Jaya, Selangor, 47500
South Korea6 sites, 6 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang, 14068
- Recruiting
Pusan National University Hospital
Busan, 49241
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
- Recruiting
Severance Hospital - Yonsei Cancer Center
Seoul, 03722
- Recruiting
Samsung Medical Center
Soeul, 06351
- Recruiting
Ajou University Hospital
Suwon, 16499
Sri Lanka5 sites, 5 recruiting
- Not yet recruiting
National Hospital of Sri Lanka
Colombo, 00700
- Not yet recruiting
Jaffna Teaching Hospital
Jaffna, 40000
- Not yet recruiting
Kandy National Hospital
Kandy, 20000
- Not yet recruiting
Kurunegala Teaching Hospital
Kurunegala, 60000
- Not yet recruiting
Kothalawala Defence University Hospital
Werahera, 10290
United Kingdom5 sites, 4 recruiting
- Recruiting
Royal Derby Hospital
Derby, DE22 3NE
Michelle Skupian, +1 857 314 1961, clinicaltrials@waldenbiosciences.com
- Recruiting
College of Life Sciences, University of Leicester
Leicester, LE1 7RH
Michelle Skupian
+1 8573141961, clinicaltrials@waldenbiosciences.com
- Withdrawn
Barts Health NHS Trust
London, E1 2ES
- Not yet recruiting
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Michelle Skupian
+1 8573141961, clinicaltrials@waldenbiosciences.com
- Not yet recruiting
Salford Royal NHS Foundation Trust
Salford, M6 8HD
michelle Skupian
+1 8573141961, clinicaltrials@waldenbiosciences.com
Australia2 sites, 2 recruiting
- Recruiting
Western Health Sunshine Hospital
St Albans, Victoria, 3021
Michelle Skupien, +18573141961, clinicaltrials@waldenbiosciences.com
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Michelle Skupien, +18573141961, clinicaltrials@waldenbiosciences.com
About this study
Official title: Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria
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.
- Conditions
- Diabetic Nephropathies, Primary Focal Segmental Glomerulosclerosis, Minimal Change Disease, Primary Immunoglobulin A Nephropathy, Primary Membranous Nephropathy
- Being tested
- WAL0921, Placebo
- Keywords
- DN, FSGS, TR-MCD, IgAN, PMN
- Medical subject headings
- Diabetic Nephropathies, Nephrosis, Lipoid, Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAL0921Drug
Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions.
PlaceboDrug
Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.
| Study group | Role | What they receive |
|---|---|---|
| WAL0921 | Experimental | Intravenous infusion of investigational drug WAL0921 Receives: Drug: WAL0921 |
| Placebo | Placebo comparator | Intravenous infusion of normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Measured: Baseline to Week 36
Secondary outcomes (4)
Change in albuminuria
Percent change in urine albumin-creatinine ratio (UACR)
Measured: Baseline up to Week 24
Change in proteinuria
Percent change in urine protein-creatinine ratio (UPCR)
Measured: Baseline up to Week 24
Change in estimated glomerular filtration rate
Percent change in estimated glomerular filtration rate (eGFR)
Measured: Baseline up to Week 24
Change in rate of change in eGFR
Slope of eGFR
Measured: Baseline up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start2 Jul 2024
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walden Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rekha Abichandani, MD, Study director, Walden Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466135
- Sponsor's protocol ID
- WAL0921-02
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No