Trial for cats with chronic kidney disease (CKD)
Evaluation of the effectiveness of low-dose meloxicam (Metacam®) in slowing the progression of renal dysfunction in cats with chronic kidney disease.
Purpose and Brief Study Description:
Chronic kidney disease (CKD) is common in cats, especially geriatric cats, affecting approximately 30% of cats ≥ 15 years of age and is the leading cause of death/euthanasia among geriatric cats. Without dialysis and renal transplantation, improvement of kidney function in cats with CKD is not possible. Current treatment is aimed at slowing the progressive nature of the disease. Due to the complexity of various pathways that lead to renal fibrosis, a multimodal treatment regimen is most likely to be effective. To date however, dietary therapy is the only treatment proven to slow kidney disease progression and increase survival time in cats with CKD. New treatments designed to slow the loss of nephrons and fibrosis in cats with CKD are needed. Based on two different preliminary studies conducted in Australia, cats with CKD treated with low-dose Meloxicam (a non-steroidal anti-inflammatory drug) had more stable kidney disease, improved quality of life, and longer life expectancy compared with cats with CKD that were not treated with the low-dose Meloxicam.
To further evaluate if low-dose Meloxicam treatment can slow CKD progression in cats and improve survival time. Allowing your cat to participate in this study may extend and improve his/her quality of life and contribute to research that will change the way we treat CKD in the future.
Cats with stable CKD are eligible for inclusion in this study. The CKD must be mild to moderate and stable (IRIS Stage II and early stage III CKD) with serum creatinine concentrations ≥ 2.0 but ≤ 4.0 mg/dl. Cats with concurrent systemic hypertension and/or proteinuria may be included. Once enrolled, all cats in this trial must eat only the prescription food (that is provided by the study) for the duration of the trial.
What does enrollment into this trial involve?
CKD will be confirmed and other concurrent disease ruled out at the initial visit via CBC, serum biochemistry panel, serum SDMA concentration, urinalysis with sediment examination, UP:C, plasma clearance of Iohexol, aerobic bacterial urine culture, total T4, thoracic radiographs, abdominal radiographs and ultrasound, and Doppler blood pressure. Stable kidney disease will be confirmed at a follow up visit approximately 2 weeks later by demonstrating a < 20% variation in serum creatinine. The study will be double-blinded and cats will be randomized into meloxicam-treated and placebo-treated control groups. Renal function will be monitored at 1, 3, and 6 months via CBC, serum biochemistry panel, serum SDMA concentration, plasma clearance of Iohexol, urinalysis with sediment, UP:C, and Doppler blood pressure.
The cost of the medications, examinations, diagnostics, and follow up visits are covered by the study. In addition, cats enrolled in this study will receive prescription food and medication for the six months of the study.
Please contact Dr. Greg Grauer or Dr. Chris George at (785)532-5555, or the Clinical Trials Coordinator at the Veterinary Health Center at (785)532-3046 or firstname.lastname@example.org for more information about this study.