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A Blinded, Randomized, and Placebo-Controlled Clinical Trial of a Novel Veterinary Product for the Management of Chronic Kidney Disease in Cats

Principle Investigator

Dr. Autumn Harris

Description

Evidence exists to suggest that aging of the kidney may contribute to the onset and progression of chronic kidney disease (CKD). Rapamycin is a drug that is a known modulator of the aging process and additionally may decrease the formation of fibrosis (scarring) in the kidney. A feline formulation of the drug is available, and this study aims to assess the potential benefit of the drug in cats with CKD.

Testing Requirements

Participation:

1. At the time of screening, your cat will receive a physical examination and comprehensive laboratory screening to confirm stage of CKD and exclude other newly diagnosed conditions (eg. hyperthyroidism, hypertension).

2. At one of the screening visits an abdominal ultrasound and radiographs will also be performed (these procedures typically require light sedation).

3. After confirmation of enrollment, your cat will be randomized to receive Rapamycin or placebo which will be administered orally as a whole tablet (followed with water or food to ensure swallowing) once weekly for ~40 weeks (270 days). Some cats may require two tablets per dose.

4. You will be asked to bring your cat back for four recheck visits (day 30, 90, 180 and 270) for a physical exam, blood and urine collection and blood pressure measurement.

Participation

participation guidelines for study

Enrollment Start

12/15/2024

Enrollment Finish

02/01/2026

Eligibility

Inclusion Criteria

1. Cats diagnosed with IRIS Stage II or III chronic kidney disease
– Based on elevated serum creatinine (1.6 – 4.9 mg/dL) with USG < 1.035

2. Cats must be amenable to pill administration

3. Cats must be fed a stable diet for at least 28 days with a commitment to not substantially alter the diet during the study period.

4. Cats must have a body weight ≥ 2.2 kg (~5lbs)

5. Cats must ≥ 5 years and < 15 years of age

Flyer

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Contact

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