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Kidney DiseasePhase 2BREAKOUTNCT05709444

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

A Phase 2 study testing Bremelanotide and RAAS inhibition therapy in people with Kidney Disease, run by Palatin Technologies, Inc at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Kidney Disease
What is being tested?
Bremelanotide and RAAS inhibition therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
9 sitesUnited States
Study dates
26 Dec 2022to 26 Apr 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged between 18 years and 80 years, inclusive, 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.
  • Have a diagnosis of Type II diabetes mellitus in a controlled state (defined as Hemoglobin A1c (HgbA1c) ≤ 10%). Note: Efforts will be made to enroll subjects with known diabetic retinopathy and diabetic peripheral neuropathy to examine the potential benefits of melanocortin receptor activation outside kidney disorders.
  • Have a BMI ≤ 45 kg/m^2 at screening.
  • Have a diagnosis of Stage I, II, or III diabetic nephropathy, confirmed by renal biopsy within 5 years of Screening.
  • Have been on a stable dose of oral diabetic agents or insulin injections for ≥3 months prior to enrollment. Sliding scale dose of insulin based on blood sugar readings is acceptable as long as the type of insulin has remained stable.
  • Be on a stable, maximum tolerated dose (as determined by the Investigator) of an angiotensin-converting enzyme (ACE) or angiotensin-receptor blockers (ARB) as primary antihypertensive therapy (blood pressure of <140/90 at screening).
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  • Note: If the blood pressure is >140/90 at screening it can be repeated twice and if it is <140/90 upon repeat the subject is eligible for study enrollment.
  • Note: The addition or dose modification of ACE-ARB agents after consent is not allowed unless for a safety reason and in consultation with the Medical Monitor prior to adding or modifying.
  • Note: Subjects requiring additional medications to achieve the target blood pressure will use antihypertensive agents that have neutral effects on urinary proteinuria (e.g., Hydralazine or long-acting Dihydropyridine calcium channel blockers, etc.).
  • Any subject taking Finerenone, Spironolactone, Eplerenone or any other mineralocorticoid receptor antagonists (MRAs), SGLT inhibitors, and non-dihydropyridine channel blockers (e.g., Diltiazem and Verapamil) must have been on a stable dose for ≥3 months prior to enrollment.
  • Note: The addition or dose modification of these agents after consent is not allowed unless for a safety reason and in consultation with the Medical Monitor prior to adding or modifying.
  • Any subject taking a medication that the Investigator believes could alter urinary protein or eGFR must agree to maintain a stable dose throughout the study period, including SGLT2 inhibitors.
  • Note: Insulin and other diabetic agents can be adjusted for glycemic control.
  • Have an eGFR by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥20ml/min/1.73m^2, at screening.
  • At screening, two first morning urinary voids obtained with an average UP/Cr ratio of >1,000 mg/gm. If the FMV values are not met, a 24-hour urine collection of protein can be completed and must average UP/Cr ratio of > 1,000 mg/gm for study inclusion.
  • For female subjects:
  • Women of childbearing potential (WOCBP) must agree to abstain from heterosexual intercourse or use a highly effective contraceptive(s) (with a failure rate of <1% per year), as described in the protocol, during the treatment and follow-up and for at least 90 days after the last dose of BMT. Female Subjects must agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this 90-day period. Hormonal-based contraception is to be employed for a minimum of 28 days prior to Day 0. The Investigator should evaluate the effectiveness of the contraception method in relation to the dose of the investigational product. Note: Oral hormonal contraceptives should be combined estrogen and progesterone. If a progesterone-only oral contraceptive is used, then a second method of birth control should be used as well.
  • Alternatively, a female of non-childbearing potential is defined as:
  • Age ≥ 50 years, no menses for at least one year, per subject self-report. ii. Documented hysterectomy, bilateral tubal ligation, or bilateral oophorectomy.
  • For male subjects:
  • Agree to abstain from heterosexual intercourse or use double barrier protection with condom and spermicide with any WOCBP sexual partner from screening and continuing for at least 30 days after the administration of BMT. Male subjects must also agree not to donate sperm during these 30 days.
  • Alternatively, documented sterilization confirmed by the absence of sperm in the ejaculate or ≥ one-year post-operative from vasectomy.

Who cannot join

  • Subjects will be excluded from the trial if they meet any of the following criteria:
  • Females who are pregnant or breastfeeding or plan to become pregnant or donate ova during the trial or 30 days after trial participation.
  • Has a known allergy or intolerance to AECI, ARB, or Melanocortin peptides.
  • Patients with a positive Serum Antigen/Antibody Hepatitis Panel (Hep B and C) and HIV antibody test Human Immunodeficiency Virus (HIV) antibody.
  • Note: Patient with positive hepatitis C antibody but negative PCR test for active Hepatitis C viral shedding will be allowed to participate in the study. Patients with a positive Hepatitis B surface antigen antibody or core antigen antibody will be allowed to participate in the study. Patients with circulating hepatitis B surface antigen or have a positive PCR test for active hepatitis B virus will NOT be allowed to participate in the study.
  • Patients with a known active history of alcohol dependence and/or drug use (with Cannabis exception) will be excluded from the study.
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  • Has significant medical illnesses that cannot be adequately controlled with appropriate therapy and may obscure toxicity, dangerously alter drug metabolism, or compromise the subject's ability to participate in the trial, as determined by the Investigator.
  • Has current or prior receipt of bremelanotide therapy within the past year.
  • Has used cyclosporine A, adrenocorticotropic hormones, long-term corticosteroids (> 20 mg qd or its equivalent for > 3 months), or cytotoxic agents within the past 3 months.
  • Has a known positive ANA, or Anti-ds-DNA serology and considered by the site principal investigator to have active lupus will NOT be allowed to participate in the study. Patients with a positive RPR but a negative FTA test will be allowed to participate in the study. Patients with a positive Anti-PR3 or Anti-MPO antibody test and thought to have a clinical presentation consistent with ANCA vasculitis will NOT be allowed to participate in the study.
  • Has a solitary kidney (acute kidney injury "AKI" risk) or is on dialysis.
  • Has compromising heart failure or other cardiomyopathies in the opinion of the site Investigator.
  • Has a known history of hyperosmolar states (requiring hospitalization within two months of screening), non-diabetic glomerular disease (with the exclusion of hypertensive glomerulopathy), AKI (requiring renal replacement therapy within two months of screening), kidney transplant, cancer (within 2 years of screening with the exception of non-melanoma skin cancer).
  • Has symptomatic and clinically significant hypotension or dehydration, as determined by the Investigator.
  • Has taken any experimental drug or therapy within 28 days / 5 half-lives of trial treatment or concurrently participating in another clinical trial.
  • Has a history of clinically significant bradycardia and/or a heart rate less than 50 bpm at screening.
  • Plan for blood donations during the study and within 30 days following completion of or early discontinuation from the trial.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Northeast Research Center, LLC

    Bethlehem, Pennsylvania, 18017

  • California Institute of Renal Research

    Chula Vista, California, 91910

  • Nephrotex Research Group

    Dallas, Texas, 75231

  • Georgia Nephrology, LLC DBA -GA Nephrology Research Institute

    Decatur, Georgia, 30030

  • Prolator Clinical Research Center

    Houston, Texas, 77030

  • California Institute of Renal Research DBA - Balboa Research

    La Mesa, California, 91942

  • Georgia Nephrology, LLC [DBA] GA Nephrology Research Institute

    Lawrenceville, Georgia, 30046

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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

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.

Read the 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
Being tested
Bremelanotide, RAAS inhibition therapy
Medical subject headings
Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BremelanotideDrug

    Also called Bremelanotide acetate

    Bremelanotide is a cyclic, heptapeptide analog of the endogenous peptide alpha melanocortin stimulating hormone (αMSH).

  • RAAS inhibition therapyDrug

    Also called Angiotensin-converting enzyme (ACE) inhibitors, Angiotensin II receptor blockers (ARBs)

    RAS-acting agents are medicines acting on a hormone system that helps to control blood pressure and the amount of fluid in the body.

Study groups in NCT05709444
Study groupRoleWhat they receive
Subcutaneous BremelanotideExperimentalBMT sterile aqueous solution for injection provided as a prefilled syringe, administered by subcutaneous (SQ) injection into the abdomen.
Receives: Drug: Bremelanotide; Drug: RAAS inhibition therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To demonstrate the efficacy of 0.5 mg subcutaneous BMT (given twice a day), used in combination with a subject's maximum tolerated dose of RAAS inhibition therapy, reduces urinary protein by 50% from baseline UP/Cr levels.

    Proportion of subjects with Type II diabetic nephropathy who achieve a 50% reduction in their urine protein Cr (UP/Cr) ratio after six months of combined therapy (RAAS inhibition therapy plus BMT). Inhibition therapy to reduce urinary protein and maintain podocyte density and functions in subjects with Type II diabetic nephropathy after six months.

    Measured: Baseline to after six months of combined therapy (RAAS inhibition therapy plus BMT).

  2. 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.

    Proportion of subjects with Type II diabetic nephropathy who achieve a 50% reduction in their urine protein Cr (UP/Cr) ratio after six months of combined therapy (RAAS inhibition therapy plus BMT) to determine the incidence of adverse events, related adverse events, adverse events of special interest, serious adverse events and BMT discontinuation.

    Measured: Baseline to after six months of combined therapy (RAAS inhibition therapy plus BMT).

Secondary outcomes (4)

  1. To evaluate the percentage of patients receiving SQ BMT in combination with RAAS inhibition to achieve a complete remission defined as a UP/Cr ratio of ≤ 500 mg/gm at 6 months.

    Clinical Remission: Proportion of subjects that achieve a reduction in UP/Cr ratios of ≤ 500 mg/gm at 6 months.

    Measured: < 500 mg/gm at 6 months.

  2. To evaluate the percentage of patients receiving SQ BMT in combination with RAAS inhibition to achieve partial remission defined as a UP/Cr ratio of ≥ 50% reduction from baseline UP/Cr at 6 months.

    Partial Remission: Proportion of subjects that achieve a reduction in UP/Cr ratios of ≥ 50% reduction from baseline UP/Cr at 6 months.

    Measured: ≥ 50% reduction from baseline UP/Cr at 6 months.

  3. To determine the percentage of patients to achieve a clinical response defined as ≥ 30% reduction from BL UP/Cr at 6 months.

    Proportion of subjects that achieve a reduction in UP/Cr ratios of ≥ 30% reduction from baseline UP/Cr at 6 months.

    Measured: ≥ 30% reduction from BL UP/Cr at 6 months.

  4. To measure the percentage of subjects receiving SQ BMT in combination with RAAS inhibition therapy whose eGFR decreases by less than 5.0 mL/min/1.73m2 from baseline at 6 months.

    Proportion of subjects with Type II diabetic Nephropathy receiving maximally tolerated renin-angiotensin (RAAS) blockade, experiencing a reduction in eGFR of less than 5.0 mL/min/1.73m2 from baseline at 6 months.

    Measured: <5.0mL/min/1.73m^2 from baseline at 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start26 Dec 2022
  3. Primary completion26 Apr 2024
  4. Study completion26 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This trial 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.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05709444
Sponsor's protocol ID
BMT-701
Acronym
BREAKOUT
Status last verified
Dec 2023
First submitted
6 Jan 2023
Last updated
17 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bremelanotide and RAAS inhibition therapy in people with Kidney Disease, run by Palatin Technologies, Inc at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To demonstrate the efficacy of 0.5 mg subcutaneous BMT (given twice a day), used in combination with a subject's maximum tolerated dose of RAAS inhibition therapy, reduces urinary protein by 50% from baseline UP/Cr levels. (time frame: Baseline to after six months of combined therapy (RAAS inhibition therapy plus BMT).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05709444.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.

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