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Looking for participantsPhase2

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Sponsor: Walden Biosciences

NCT ID: NCT06466135

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
WAL0921 (drug), Placebo (drug)
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
WAL0921 — drug: Investigational drug WAL0921 Participants receive an intravenous infusion of WAL0921 investigational drug once every 2 weeks for 7 total infusions. · Placebo — drug: Placebo product Participants receive an intravenous infusion of placebo once every 2 weeks for 7 total infusions.
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a medicine called WAL0921 in adults with certain kidney diseases that affect the filters in the kidneys (glomerular kidney diseases). These include diabetic kidney disease and several other conditions. Not stated — ask the trial team for details on how the treatment works.

Who can take part

  • Adults aged 18 to 75
  • Diagnosis of one of these kidney diseases: diabetic nephropathy, primary focal segmental glomerulosclerosis (scarring of kidney filters), treatment-resistant minimal change disease, primary immunoglobulin A (IgA) nephropathy, or primary membranous nephropathy
  • Kidney filtration rate (eGFR) of 30 or higher

Who may not be able to

  • Currently pregnant or planning to become pregnant
  • Previous organ transplant
  • History of alcohol or substance use disorder
  • Dialysis or sudden kidney injury within the last 6 months
  • Any other condition that, in the doctor's judgement, would make taking part unsafe or prevent completing the study

What taking part involves

  • • Taking the study medicine WAL0921 — details of how it is given are not stated — ask the trial team

Time commitment: Number of visits and study length are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
96
Started
2024-07-02
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for diabetic nephropathies
  • • Phase2 - 96 participants
  • • 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 \[PMN\])

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with diabetic nephropathies

Where?

  • • Derby - Royal Derby Hospital
  • • Leicester - College of Life Sciences, University of Leicester
  • • London - Barts Health NHS Trust
  • • Manchester - Manchester University NHS Foundation Trust
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About 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.

Diabetic NephropathiesPrimary Focal Segmental GlomerulosclerosisMinimal Change DiseasePrimary Immunoglobulin A NephropathyPrimary Membranous Nephropathy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Adults, age 18-75 years
  • ✓eGFR greater than or equal to 30 mL/min/1.73 m2

Who cannot take 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 prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from...
See the full criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Where Is This Study? (5 UK sites)

Royal Derby Hospital

Derby DE22 3NE, United Kingdom

Recruiting
Site contact (verified)

College of Life Sciences, University of Leicester

Leicester LE1 7RH, United Kingdom

Recruiting

Barts Health NHS Trust

London E1 2ES, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Manchester University NHS Foundation Trust

Manchester M13 9WL, United Kingdom

NOT_YET_RECRUITING

Salford Royal NHS Foundation Trust

Salford M6 8HD, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

Michelle Skupien

Sponsor contact

CONTACT

8573141961 clinicaltrials@waldenbiosciences.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07