Purpose and Brief Explanation of Study:
The purpose of this study is to evaluate the safety and mechanism of action of an investigational veterinary product (IVP) that is believed to be important in the disease process of canine chronic kidney disease (CKD) and its sequelae, mineral and bone disorder (MBD).
What qualifies my dog for enrollment in this in this trial?
Your dog may qualify to participate in this clinical trial if it meets these requirements:
- Be at least one year of age and weigh at least 5 kg (11 pounds).
- Be diagnosed with CKD, specifically International Renal Interest Society (IRIS) stage 2, 3 or 4.
If my dog qualifies for enrollment, what does enrolling my dog in this clinical trial involve?
Once your dog enrolls, blood and urine samples will be taken to monitor the health status and the stage of the kidney disease. At your baseline visit, depending on the stage of CKD, your dog may also need to undergo a special X-Ray like diagnostic procedure called Dual-Enerdy X-ray Absorptiometry (DEXA) scan. Your dog will receive his/her first dose of the IVP at the second visit and every 14 days thereafter.
After the baseline visit, you should be prepared to attend regular clinic appointments with your dog. For the first 28 days on study, your dog will require weekly visits. Thereafter, visits will be every two weeks. It is important that these visits occur within a consistent time period in a given day; your Veterinarian will explain exactly when these visits should take place. At each of these clinic visits, your study Veterinarian will examine your dog and may collect blood and urine samples to monitor the health status of your dog. You will be also asked to complete the questionnaire about the health status and the quality of life of your dog at each visit. Depending on the stage of CKD your dog has, a DEXA scan may be repeated an additional 1 – 2 times at least three months apart during the study.
For enrolled dogs, the clinical trial will cover all costs associated with every scheduled study visit (Physical Exams, blood and urine tests, blood pressure evaluation, etc.). Additionally pet owners will receive $75 credit per visit to be used at the veterinary medical center.
If you believe your pet may be eligible to enter this study, please click here to fill out a questionnaire.
Please contact the Clinical Trials Office at the Veterinary Medical Center for more information about this study.