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

NCT05709444 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-10-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Palatin Technologies, Inc

    lead INDUSTRY

Principal Investigators

  • Robert Jordan · Palatin

  • James Tumlin, MD · Georgia Nephrology Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-26
Primary Completion
2024-04-26
Completion
2024-04-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05709444 on ClinicalTrials.gov