Principle Investigator

Dr. Autum Harris

Description

The objective of this study is to evaluate whether a monoclonal antibody targeting transforming growth factor beta (TGF-β) can slow the progression of chronic kidney disease (CKD) in dogs with early-stage disease. Chronic kidney disease is a progressive condition in which long-term kidney damage can lead to worsening kidney function over time. Current therapies for CKD are largely supportive and are not
specifically designed to slow or reverse the underlying kidney injury.

This study will evaluate the effects of an investigational anti–TGF-β monoclonal antibody (ZTS-00521426) in dogs with stable IRIS Stage 1 or Stage 2 CKD. Dogs enrolled in the study will receive monthly subcutaneous injections of either the investigational treatment or placebo throughout the study period. The study will evaluate changes in kidney pathology and kidney health over time.

At each study visit, your veterinarian will examine your dog and monitor overall health. Blood and urine samples will be collected regularly to assess kidney function and monitor for disease progression. Additional evaluations may include blood pressure measurements and specialized laboratory testing. Dogs enrolled in the study must have previously undergone a kidney biopsy confirming CKD diagnosis.

Testing Requirements

A summary of anticipated study events is presented in the diagram below. No changes
in medications or diet should be made during the study without first discussing them
with the study team.

Study visits include screening evaluations beginning approximately 56 days prior to
treatment initiation, followed by monthly visits for study treatment administration and
monitoring. Procedures performed during the study may include:

Physical examinations
Blood pressure measurements
Bloodwork (CBC, chemistry panel with SDMA, NT-proBNP, PTH, total T4)
Urinalysis and urine protein:creatinine ratio (UPC)
Urine culture
Tick-borne disease testing
Monthly subcutaneous study injections
Repeat kidney biopsy at study completion

Treatment injections are administered monthly at NC State Veterinary Hospital.

Enrollment Start

07/01/2026

Enrollment Finish

07/01/2029

Eligibility

1. Dogs diagnosed with stable IRIS Stage 1 or Stage 2 CKD based on at least one of the following:
o Inadequately concentrated urine (typically urine specific gravity [USG] <1.030)
o Serum creatinine concentration between 1.4–2.8 mg/dL
o Persistent renal proteinuria (UPC > 0.5)
o Persistent SDMA concentration >14 μg/dL

2. Dogs must be at least two years of age and weigh at least 2.0 kg.

3. Dogs must have had a kidney biopsy submitted to IVRPS within three months prior to enrollment confirming CKD diagnosis.

4. Dogs must otherwise be considered stable and suitable for study participation by the study investigators.

Flyer

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Contact

For more information, please contact the Harris Lab at: harrislab-clinicaltrials@ncsu.edu