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PROTOCOL to the Azodyl Renal Failure Trial
Multi-center, double-blinded prospective study. One hundred cats will be randomly assigned to receive either Azodyl (1 to 3 capsules daily) or placebo. The dosages chosen for the Azodyl are based on manufacturer recommendations.
Inclusion criteria: Cats of any age and sex will be eligible for study entry. Cats must have previously documented chronic renal failure which is not rapidly progressive and of at least 2 months duration. "Rapidly progressive" is defined as significantly worsening indices of renal function over the previous 2-6 months or development of uremia in the previous 2-6 months. Cats must have objective evidence of non-infectious chronic renal failure, as determined by elevated blood urea nitrogen (BUN) and creatinine (Creat) with inappropriate urine concentrating ability (USG < 1.030). Owners will complete a monthly survey that will record appetite, activity, psychological status, thirst, degree of interaction with owner, and side effects of medication prior to routine sampling. Cats with controlled hypertension are eligible.
Exclusion criteria: Cats with chronic renal failure diagnosed less than 2 months.
Definition of Chronic Renal Failure:
Elevation in BUN and Creatinine with inappropriate urine concentrating ability of at least 2 months duration. Cats should generally demonstrate weight loss at time of initial diagnosis, and have polyuria and polydipsia as a presenting clinical finding. Urine culture, if performed, should be negative. Non-regenerative anemia may be present. Physical exam findings may include abnormally palpable kidneys.
Blinding procedures: In order to avoid bias, primary care clinicians and owners will not be provided details of the biochemical tests during the study UNLESS clinically mandated by the primary care clinician. If results are required for acute management decisions, the investigators should be contacted.
Dosing protocol: Cats < 5lbs: 1 capsule daily (AM) sprinkled onto food
Concurrent Medications and Therapies:Cats enrolled in the study may receive additional medications and therapies for their renal failure throughout the course of the trial, provided these therapies have been administered routinely for at least 2 months prior to enrollment in the clinical trial. The medications should be continued for the duration of the trial at the same doses and dosing frequencies.
Completion of 3-month study.
Study Drugs (Azodyl or placebo) supplied by principal investigators
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