What is the REVERSE Study?
The REVERSE study is a placebo-controlled clinical trial to evaluate the effectiveness of TRIV307 in managing the progression of Chronic Kidney Disease (CKD) in client owned cats over a 9 month period.
Two study groups are used in this study, and you will not know which of the groups your cat is enrolled in. The groups include a placebo group that receives a pill with no active compound, and a treatment group that receives a TRIV307 pill. This study is blinded, meaning some of the individuals helping with the study, including you and the study veterinarian, will not know which treatment group your cat has been assigned to. The placebo and TRIV307 pills look identical, and they are to be given by mouth once weekly.
There are no costs to you for participating in this study. All study related activities (physical exams, blood work, urinalysis, diagnostic imaging, etc.) will be provided at no expense to you.
REVERSE Study Eligibility Requirements
As for any clinical study, there is a detailed list of inclusion and exclusion criteria to ensure that the REVERSE study findings are valid and robust, and that the safety and welfare of the participating cats are protected. Male, and surgically spayed female, cats with IRIS stage II or III CKD may be eligible if they meet these additional criteria:
• Body weight ≥2.2 kg (4.85 lb)
• Age ≥5 years and <17 years at enrolment
• Willing to take oral medications
• Otherwise healthy; e.g. Does not have diabetes mellitus
• Their owner provides consent after being informed of the risks and benefits of participation in the study
REVERSE study Investigators will carefully examine all cats to determine whether they are suitable for inclusion in the study in consideration of a detailed list of criteria.
At your first visit to the clinic, your cat will undergo a thorough physical examination, blood, urine, abdominal screening (ultrasound and radiograph evaluations). Additional tests may be performed at the discretion of the study veterinarian, and your cat may receive a mild sedative if required to reduce stress. You will also be asked to complete a quality-of-life questionnaire. None of these procedures will be carried out until all the risks and benefits of taking part in the study are explained to you, and you have provided your informed consent for participation in writing
What Else is Required for REVERSE Study Participation?
Taking part in a clinical study like REVERSE is a big commitment. In addition to the screening visit(s), you will return to the clinic with your cat for follow-up evaluations 5 times over the course of the 9 months. You will also return to the clinic in the days following the enrolment visit to collect the first supply of study drug; however, your cat does not need to accompany you for this visit. You must continue to dose your cat with the study medication, as well as any other medications deemed necessary by your study veterinarian, for the course of the study. It is essential that owners registering for REVERSE are able to meet these requirements so that we can accurately assess the effects of treatment with TRIV307 when the study concludes.
