Evaluation of Kidney Pathology After Investigational Treatment in Dogs with Chronic Kidney Disease

In dogs with chronic kidney disease (CKD), the available medical management consists of supportive and symptomatic treatment with the goal of correcting the associated clinical and metabolic abnormalities. None of the available therapies are aimed at slowing or reversing the underlying kidney disease. Thus, there is an unmet need for alternative therapies for this life-threatening, progressive disease. The primary objective of this study is to evaluate kidney pathology following investigational treatment in dogs with IRIS stage 1 and stage 2 CKD. The secondary objective of this study is to evaluate biomarker changes over the course of the study.

Inclusion Criteria

• Dog has had a kidney biopsy within 3 months of Day -56 and pathology results confirm CKD based on interstitial fibrosis and/or evidence of glomerulosclerosis
• Diagnosis of IRIS stage 1 or Stage 2 CKD
• Dog is in a stable state of CKD (no AKI events in the past three months)
• At least 1 year of age and at least 1 kg
• In otherwise good general health or with stable chronic conditions

Exclusion Criteria

• Dogs with a diagnosis of:
• Primary hyperparathyroidism or primary hypoparathyroidism
• Protein-losing enteropathy
• Polycystic kidney disease
• Hypercalcemia of non-renal or non-renal secondary hyperparathyroid origin
• Post-renal azotemia such as obstructive lower urinary tract disease/urolithiasis
• Any current malignant or suspected malignant neoplasia (previous malignancies that have been excised/cured may be enrolled)
• Congestive heart failure requiring treatment with diuretics
• Another serious concurrent disease that would interfere with the objectives of the study
• Diagnosis of renal dysplasia/maldevelopment, pyelonephritis, or amyloidosis based on kidney biopsy histopathology.
• Males and females intended for breeding during the study
• Dogs eating a raw or unbalanced homemade diet
• A current diagnosis of acute kidney injury
• Dogs receiving amphotericin B, bisphosphonates or chemotherapy
• Dogs receiving treatment, or a history of requiring treatment in the last six months, for active infectious disease that secondarily cause nephropathology such as Lyme nephritis, ehrlichiosis, leishmaniosis or leptospirosis
• Dog with a procedure requiring general anesthesia scheduled within the first 6 months on study

Client Benefits

Costs of study related physical examinations and blood/urine testing will be covered by the study. Owners will be able to receive a genetic report, including breed analysis, on their dog from Basepaws.

This study is placebo controlled. Dogs have a 50% chance of receiving placebo treatment. Treatment is with an investigational product. Efficacy is not guaranteed. Dogs may remain on supportive CKD therapies as prescribed (not included in covered costs).

By participating in this study, you are making a significant contribution to canine kidney disease research. We are confident that this contribution will help understand and improve the treatment of kidney disease in dogs. Thank you for your participation.

Sample or Data Requirements

Dogs will have an initial baseline phase to confirm study eligibility and establish baseline biomarker and clinical parameters. Thess visits will occur on Day -56 and Day -28 and will include a physical examination, blood and urine collections, and owner assessments. Dogs will return to the clinic for visits including a physical examination, blood and urine collection, investigational treatment and owner assessment on study days 0, 28, 56, 84, 112, 168, 224, 280 and 336. Dogs will return to the clinic on days 140, 196, 252, and 308 for investigational treatment only. Additionally, on day 336, dogs will have a post-treatment kidney biopsy collected.

When required, 7 mL of blood and 5 mL of urine will be collected. Urine will be collected via cystocentesis. Samples should be collected within 2 hours of the Day -56 collection time.

When required, owners will complete an assessment evaluating the overall clinical condition of their dog related to CKD by using a CKD health-related quality of life questionnaire that consists of 13 questions. Questionnaires will ideally be completed via an electronic link sent to their email.

Contact Information

For questions regarding the clinical trial, please email clinicaltrials@tufts.edu.