NCT05709444

A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease

A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease to Assess the Efficacy in Reducing Urinary Protein and Maintaining Podocyte Density and Function

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Palatin Technologies, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label trial to assess the efficacy of melanocortin receptor agonist bremelanotide (BMT) when administered with RAAS inhibition therapy after six months in subjects with Type II diabetic nephropathy. After six months of therapy, all subjects will remain in trial for further assessment and undergo a diagnostic renal biopsy to assess the effect of melanocortin therapy on diabetic histopathology at 12 months.

Detailed description

A total of 45 subjects with biopsy-proven Type II diabetic nephropathy and \>1000 mg/gm UP/Cr ratio will be enrolled to receive BMT therapy in addition to their maximum tolerated RAAS inhibition therapy for six months. The subjects' historical medical and laboratory data collected at four timepoints, approximately 24, 18, 12, and 6 months prior to Day 0, will be reviewed and recorded to be used as baseline values.

Conditions

• Kidney Disease

Interventions

Type	Name	Description
DRUG	Bremelanotide	Bremelanotide is a cyclic, heptapeptide analog of the endogenous peptide alpha melanocortin stimulating hormone (αMSH).
DRUG	RAAS inhibition therapy	RAS-acting agents are medicines acting on a hormone system that helps to control blood pressure and the amount of fluid in the body.

Timeline

• Start date: 2022-12-26
• Primary completion: 2024-04-26
• Completion: 2024-04-26
• First posted: 2023-02-02
• Last updated: 2024-10-17

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study