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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up >50% from baseline, and to a level < 1000 mg/gm, at six months
Awards & highlights
BREAKOUT Trial 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.
BREAKOUT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with early to advanced stage kidney disease due to diabetes within the past 5 years.
Select...
You are taking the highest dose of ACE or ARB medication for high blood pressure and your blood pressure is under control.
BREAKOUT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ >30% from baseline at six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~>30% from baseline at six months
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
BREAKOUT 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken bremelanotide in the last year.You have used certain medications like cyclosporine A, adrenocorticotropic hormones, long-term corticosteroids, or cytotoxic agents in the past 3 months.You have been diagnosed with early to advanced stage kidney disease due to diabetes within the past 5 years.You are taking the highest dose of ACE or ARB medication for high blood pressure and your blood pressure is under control.Your kidney function, measured by eGFR, needs to be at least 20ml/min/1.73m^2.You don't have a history of a very slow heart rate or a heart rate less than 50 beats per minute during screening.Your first urine sample in the morning shows a high protein-to-creatinine ratio.You have a positive test for certain antibodies that indicate active lupus, as determined by the study doctor.You have only one working kidney or are currently undergoing dialysis.You have a heart condition that the doctor thinks could be risky for the study.You have a history of certain kidney problems, recent cancer (except for non-melanoma skin cancer), or certain medical conditions related to high blood sugar levels.You have low blood pressure or severe dehydration with noticeable symptoms.You have Type II diabetes that is well managed, with a HgbA1c level below 10%.You have had a slow heart rate in the past or your current heart rate is less than 50 beats per minute.Your body mass index (BMI) is less than 45.You have allergies or negative reactions to AECI, ARB, or Melanocortin peptides.You have tested positive for hepatitis B, hepatitis C, or HIV.You have a history of regular alcohol or drug dependence, except for cannabis.
Research Study Groups:
This trial has the following groups:- Group 1: Subcutaneous Bremelanotide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial actively recruiting participants?
"This clinical trial is currently recruiting participants, as indicated in its listing on clinicaltrials.gov. Initially posted on December 29th 2022 and last updated January 23rd 2023, the study seeks suitable candidates to enroll."
Answered by AI
Is the eligibility criteria of this medical examination limited to those over twenty years old?
"As indicated by this trial's eligibility criteria, all participants must be aged between 18 and 80 years old."
Answered by AI
Has the FDA approved Subcutaneous Bremelanotide for public use?
"Subcutaneous Bremelanotide's safety is evaluated as a 2, since there are some data points to back its security but none that can vouch for its efficacy."
Answered by AI
How many centers are involved in the management of this experiment?
"At this time, 6 sites across the country are enlisting patients for the study. Potential enrollees can select from Decatur, Lawrenceville and Winston-Salem plus an additional six locations to minimize travel needs."
Answered by AI
How many individuals have agreed to participate in this experiment?
"In order to successfully launch this clinical trial, 45 qualified patients must participate. These recruits can sign up at either the Decatur or Lawrenceville branches of Georgia Nephrology Research Institute."
Answered by AI
Who meets the criteria to join this research endeavor?
"This study requires 45 individuals aged 18 to 80 that are diagnosed with kidney disease, Type II diabetes mellitus (HgbA1c ≤ 12%), BMI ≤45 kg/m^2., Stage I-III diabetic nephropathy confirmed by biopsy within the last 5 years, on a stable dose of oral diabetic agents or insulin injections for 3+ months prior to randomization, and on a stabile maximum tolerated dose of ACE or ARB as primary antihypertensive therapy. The target blood pressure must be less than 140/90 and additional medications used should have neutral effects on urinary proteinuria. Subjects taking mineralocort"
Answered by AI
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