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Melanocortin Receptor Agonist

Bremelanotide + RAAS Inhibitors for Diabetic Kidney Disease (BREAKOUT Trial)

Phase 2
Recruiting
Led By James Tumlin, MD
Research Sponsored by Palatin Technologies, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged between 18 years and 80 years, willing, and able to understand the risks of the trial and consents to trial conduct documented by the signing of the trial informed consent form.
Diagnosis of Stage I, II, or III diabetic nephropathy, confirmed by renal biopsy within 5 years of Screening
Must not have
Current or prior receipt of bremelanotide therapy within the past year
Use of cyclosporine A, adrenocorticotropic hormones, long-term corticosteroids (> 20 mg qd or its equivalent for > 3 months), or cytotoxic agents within the past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up >50% from baseline, and to a level < 1000 mg/gm, at six months
Awards & highlights

Summary

This trial will look at how an experimental drug, BMT, affects Type II diabetes when combined with other treatments. After 6 months, patients will have a biopsy to see if it worked.

Who is the study for?
Adults aged 18-80 with Type II diabetes and early-stage diabetic kidney disease, on stable blood pressure medication, can join this trial. They must not be planning to donate blood or become pregnant, have a controlled state of diabetes (HgbA1c ≤ 10%), and agree to use contraception if necessary. Exclusions include prior bremelanotide therapy, certain medications within the past year, active lupus, severe heart conditions, solitary kidney or dialysis patients.Check my eligibility
What is being tested?
The study tests bremelanotide in combination with RAAS inhibition therapy over six months for treating diabetic nephropathy. Participants will continue assessments post-treatment and undergo a renal biopsy after one year to evaluate the treatment's impact on their kidneys.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site for bremelanotide such as redness or pain; increased blood pressure; nausea; headache; dizziness; fatigue and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with early to advanced stage kidney disease due to diabetes within the past 5 years.
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You are taking the highest dose of ACE or ARB medication for high blood pressure and your blood pressure is under control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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You have taken bremelanotide in the last year.
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You have used certain medications like cyclosporine A, adrenocorticotropic hormones, long-term corticosteroids, or cytotoxic agents in the past 3 months.
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You have only one working kidney or are currently undergoing dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~>30% from baseline at six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and >30% from baseline at six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To demonstrate efficacy of subcutaneous BMT used in combination with a subject's maximum tolerated dose of RAAS inhibition therapy to reduce urinary protein and maintain podocyte density and functions in subjects with Type II diabetic nephropathy.
To determine the incidence of overall adverse events, related adverse events, a composite of adverse events of special interest, serious adverse events, and the incidence of BMT discontinuation.
Secondary outcome measures
To assess the efficacy of SQ BMT in combination with RAAS inhibition therapy to achieve complete remission.
To evaluate the efficacy of SQ BMT in combination with RAAS inhibition therapy to achieve partial remission.
To measure the efficacy of SQ BMT in combination with RAAS inhibition therapy to achieve a <1.0 ml/min/year drop in eGFR after six months

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subcutaneous BremelanotideExperimental Treatment2 Interventions
BMT sterile aqueous solution for injection provided as a prefilled syringe, administered by subcutaneous (SQ) injection into the abdomen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bremelanotide
2014
Completed Phase 3
~1670

Find a Location

Who is running the clinical trial?

Palatin Technologies, IncLead Sponsor
10 Previous Clinical Trials
2,553 Total Patients Enrolled
Robert JordanStudy DirectorPalatin
4 Previous Clinical Trials
1,486 Total Patients Enrolled
James Tumlin, MDPrincipal InvestigatorGeorgia Nephrology Research Institute
2 Previous Clinical Trials
122 Total Patients Enrolled

Media Library

Bremelanotide (Melanocortin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05709444 — Phase 2
Kidney Disease Research Study Groups: Subcutaneous Bremelanotide
Kidney Disease Clinical Trial 2023: Bremelanotide Highlights & Side Effects. Trial Name: NCT05709444 — Phase 2
Bremelanotide (Melanocortin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05709444 — Phase 2
~17 spots leftby Jul 2025
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