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Also known as KBP-5074 Capsule, KBP-5074 mineralocorticoid receptor antagonist
KBP-5074 · 2 trials · 3 indications
Change in trough cuff resting seated SBP from baseline to Day 84.
Physical exam, vital signs, EKG, clinical laboratory tests, adverse events
| Arm | Type | Description |
|---|---|---|
| KBP-5074 0.25 mg tablet | EXPERIMENTAL | KBP-5074 0.25 mg tablet QD orally, 84 days |
| KBP-5074 0.5 mg tablet | EXPERIMENTAL | KBP-5074 0.5 mg tablet QD orally, 84 days |
| Placebo tablet | PLACEBO_COMPARATOR | Placebo tablet QD orally, 84 days |
| KBP-5074 | EXPERIMENTAL | Single oral dose |
| Name | Type | Description |
|---|---|---|
| KBP-5074 0.25 mg tablet | DRUG | Oral administration, QD, 84 days |
| KBP-5074 0.5 mg tablet | DRUG | Oral administration, QD, 84 days |
| KBP-5074 | DRUG | In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours. In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session. |
Inclusion Criteria: 1. Male or female, between 18 and 85 years of age, inclusive. The lower age limit may be higher if it is legally required in the participating country; 2. Body mass index between 19 and 45 kg/m2, inclusive; 3. Stage 3B/4 CKD (defined as eGFR 15 and 44 mL/min/1.73 m2, based on th...
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KBP-5074 is an investigational small molecule developed by Novo Nordisk A/S for chronic kidney disease. It has been studied in patients with chronic kidney disease, including those with uncontrolled hypertension. It is a Phase 2 candidate and has not been approved by the FDA.
KBP-5074 is being developed for chronic kidney disease, with clinical study focused on patients who have advanced chronic kidney disease and uncontrolled hypertension. It is an investigational therapy and is not approved for any use. All studies of KBP-5074 to date have been completed.
KBP-5074 is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program studying KBP-5074 in chronic kidney disease and hypertension.
KBP-5074 is in Phase 2 development. Its Phase 2b trial in uncontrolled hypertension and advanced chronic kidney disease has been completed, and a Phase 1 pharmacokinetics study in chronic kidney disease has also been completed. KBP-5074 is investigational and has not received FDA approval.
Two completed trials have studied KBP-5074: NCT03574363, a Phase 2b study in uncontrolled hypertension and advanced chronic kidney disease that enrolled 162 participants in the United States, and NCT02837237, a Phase 1 safety, tolerability, and pharmacokinetics study in chronic kidney disease that enrolled 11 participants. Both were randomized, double-blind, and placebo-controlled.