Rapamycin: Evaluation of Effectiveness in Renal Senescence- The REVERSE Study

The University of Florida College of Veterinary Medicine is currently recruiting cats with chronic kidney disease for a clinical trial evaluating the potential benefit of the drug in cats with CKD.

Enrollment Status: Currently Enrolling

· Inclusion Criteria

1. Cats diagnosed with IRIS Stage II chronic kidney disease

§ Based on elevated serum creatinine (1.6 – 2.8 mg/dL)

2. Cats must be amenable to pill administration

3. Cats must have a bodyweight > 2.7 kg (6lbs)

· Exclusion Criteria

1. Congenital kidney disease (example: dysplasia or polycystic kidney disease), diabetes mellitus, uncontrolled systemic illnesses

2. CKD complications include kidney infection or ureteral obstruction, moderate to severe anemia (PCV < 25%), decompensated CKD requiring hospitalization, and intravenous fluid therapy.

3. Prohibited concurrent therapies include cyclosporine, cisapride, beta-blocking agents, antifungal agents, diltiazem, and other medications that could affect rapamycin concentrations.

4. 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.

· Procedures/Treatment:

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 12 weeks. Some cats may require two tablets per dose.

4. 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.

5. 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. A summary of events is presented in the table below.

Procedure Screening Visit 1

Day -42 to -14

(Screening Visit 2*)

(Day -14 to -1)

Enrollment

Day 0

Day 14

± 3

Day 42

± 7

Day 84

± 7

Informed consent X          
Medical history X (X) X X X X
Dietary history X (X) X X X X
Physical examination X (X) X X X X
Quality of life assessment     X   X X
Abdominal radiography X¥ (X¥) X¥      
Abdominal ultrasonography X¥ (X¥) X¥      
Systolic blood pressure X (X) X X X X
Hematology X (X) X X X X
Biochemistry X (X) X X X X
SDMA X   X X X X
Serum cobalamin X          
Total T4 X (X)       X
FIV/FeLV testing X          
Urinalysis X (X) X   X X
FGF-23     X   X X
Banked plasma and urine     X    X X
Drug dispensing     X X X  
Drug accountability       X X X

*Screening visit 2 will only be necessary in cats where a correctable condition is identified at the Screening 1 visit that requires a recheck prior to enrollment.

¥ Abdominal radiography and ultrasonography to be completed once; at Screening Visit 1, Screening Visit 2, or prior to enrolment on Day 0.

· Costs: There is no cost to you for enrolling your cat in this study. You will receive a complimentary physical examination for your cat and diagnostic testing. In the unlikely event that an adverse event that requires treatment occurs as a result of taking part in this study, the cost of treatment will be covered by the study.

· Contact: Please email VM-clinicalstudies@ufl.edu or call Clinical Studies at 352-294-4389 if you are interested in learning more.

· Study Investigators: Drs. Autumn N. Harris, Andrew Specht, and Kirsten Cooke

· Background: 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.

IFAS

As part of both the Institute of Food and Agricultural Sciences and the Academic Health Center, Veterinary Medicine is dedicated to advancing animal, human and environmental health through teaching, research, extension and patient care.

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