Trial · Interventional
CompletedPhase 2Registry dataA Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease
Short name BREAKOUT
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 16 participants (actual)
- Sponsor
- Palatin Technologies, Inc · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 26 Dec 2022
- Primary completion
- 26 Apr 2024
- Completion
- 26 Apr 2024
- First posted
- 2 Feb 2023
- Last update posted
- 17 Oct 2024
- Conditions
- Kidney Disease
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- BremelanotideDrug
- RAAS inhibition therapyDrug
Arms1
Experimental
Subcutaneous Bremelanotide
BMT sterile aqueous solution for injection provided as a prefilled syringe, administered by subcutaneous (SQ) injection into the abdomen.
Primary outcomes2
Outcomes the sponsor listed as primary.
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).
Registry description
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.
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.
Time frame · Baseline to after six months of combined therapy (RAAS inhibition therapy plus BMT).
Registry description
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.
Secondary outcomes(4)
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.
Time frame · < 500 mg/gm at 6 months.
Registry description
Clinical Remission: Proportion of subjects that achieve a reduction in UP/Cr ratios of ≤ 500 mg/gm at 6 months.
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.
Time frame · ≥ 50% reduction from baseline UP/Cr at 6 months.
Registry description
Partial Remission: Proportion of subjects that achieve a reduction in UP/Cr ratios of ≥ 50% reduction from baseline UP/Cr at 6 months.
To determine the percentage of patients to achieve a clinical response defined as ≥ 30% reduction from BL UP/Cr at 6 months.
Time frame · ≥ 30% reduction from BL UP/Cr at 6 months.
Registry description
Proportion of subjects that achieve a reduction in UP/Cr ratios of ≥ 30% reduction from baseline UP/Cr at 6 months.
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.
Time frame · <5.0mL/min/1.73m^2 from baseline at 6 months.
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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