Purpose and Brief Explanation of Study:
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 the purpose of this study is to assess the potential benefit of the drug in cats with CKD.
What qualifies my pet for enrollment in this in this trial?
- Cats with stable IRIS stage 2 CKD (serum creatinine ≥ 1.6 - 2.8 mg/dL)
- Amenable to pill administration
- Body weight > 2.7 kg (6 lbs)
- Other concurrent therapies such as dietary management, potassium supplementation, anti-hypertensive medications and subcutaneous fluids are acceptable if they were initiated at least 28 days prior to enrollment and are given consistently throughout the study period.
Exclusion criteria include congenital CKD (dysplasia or polycystic kidney disease), diabetes mellitus, other uncontrolled systemic illnesses, complications of CKD such as kidney infection or ureteral obstruction, moderate to severe anemia (PCV < 25%), decompensated CKD requiring hospitalization and intravenous fluid therapy. Prohibited concurrent therapies include cyclosporine, cisapride, beta-blocking agents, antifungal agents, diltiazem and other medications that could affect rapamycin concentrations.
What does enrolling my pet in this clinical trial involve?
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). At one of the screening visits an abdominal ultrasound and radiographs will also be performed (these procedures typically require light sedation).
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 12 weeks. Some cats may require two tablets per dose. You will fill out a quality of life assessment at the beginning of the study and then twice more during the study as well as an owner diary.
You will be asked to bring your cat back for three recheck visits (day 14, 42 and 84) for a physical exam, blood and urine collection and blood pressure measurement.
Your cat will receive complimentary assessment and management of disease by a board-certified specialist in feline CKD as well as standard of care laboratory monitoring regardless of study group. Cats randomized to the study drug group will possibility benefit from this therapy. There is no cost to you for enrolling your cat in this study. You will receive complimentary physical examination for your cat and diagnostic testing. You will also receive $25 per visit incentive.
If you believe your pet may be eligible to enter this study,
please fill out a pre-screening questionnaire.