RECRUITING

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria

Quick Facts

Study Start:2024-07-02
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06466135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults, age 18-65 years
  2. * 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
  3. * eGFR greater than or equal to 30 mL/min/1.73 m2
  1. * Currently pregnant or planning to become pregnant
  2. * History of organ transplantation
  3. * History of alcohol or substance use disorder
  4. * Acute dialysis or acute kidney injury within 6 months of Screening
  5. * 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

Contacts and Locations

Study Contact

Michelle Skupien
CONTACT
8573141961
clinicaltrials@waldenbiosciences.com

Principal Investigator

Andrew Blair, MD
STUDY_DIRECTOR
Walden Biosciences

Study Locations (Sites)

Colorado Kidney and Vascular Care
Denver, Colorado, 80012
United States
D & H Tamarac Research Center
Tamarac, Florida, 33321
United States

Collaborators and Investigators

Sponsor: Walden Biosciences

  • Andrew Blair, MD, STUDY_DIRECTOR, Walden Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-02
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-07-02
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • DN
  • FSGS
  • TR-MCD
  • IgAN
  • PMN

Additional Relevant MeSH Terms

  • Diabetic Nephropathies
  • Primary Focal Segmental Glomerulosclerosis
  • Minimal Change Disease
  • Primary Immunoglobulin A Nephropathy
  • Primary Membranous Nephropathy