This phase 2 trial will investigate the safety and effectiveness of KBP-5074 for the treatment of hypertension. The main outcome will be a change in blood pressure after 84 days.
The details
Hypertension or high blood pressure is a serious condition. It can lead to major cardiac events such as stroke, heart attack or death. Managing BP levels can be difficult. Drugs to treat hypertension are called anti-hypertensives (AHTs). Many patients will require several AHTs to manage BP. One type of AHTs are drugs that target the kidney. Receptors in the kidney can reduce or increase BP. Some patients with hypertension may also develop chronic kidney disease (CKD). Drugs that block mineralocorticoid receptors (MCCRs) in the kidney can improve BP control. KBP-5074 is a such a drug. This prevents a hormone called aldosterone from binding to the receptor. This reduces BP.
This trial will investigate the safety and effectiveness of KBP-5074 for the treatment of hypertension. The main outcome will be a change in BP.
Who are they looking for?
This trial will recruit 240 patients with uncontrolled hypertension.Patients must also have moderate to severe CKD. Women that can become pregnant must agree to use 2 medically accepted methods of contraception during the study and up to 3 months after. Men must agree to use condoms and spermicide. Women whose male partners are in the trial must also use contraception as mentioned.
Patients cannot take part in the trial if they have a BP higher than 180 mmHg. Patients cannot take part in the study if they have a history of highpotassium levels, kidney or heart transplant, heart failure, heart attack or stroke, hepatitis, or active infection and drug abuse. HIV, hepatitis, drug abuse problems are other exclusion criteria.
How will it work
Patients will be assigned to one of three groups. The first two groups will take two different doses of KBP-5074 once a day. Group 3 will receive a placebo. The study will last 84 days in total. Assessment will be done at the beginning of the study, during the study and at the end. Blood pressure will be measured at these assessments. Blood samples will be taken and kidney function will be measured.
The main outcome will be a change in blood pressure.
