All > Diabetic Kidney Disease

Subcutaneous Bremelanotide for Kidney Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Clinical Advancement Center, PLLC, San Antonio, TXKidney DiseaseBremelanotide - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Kidney Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 3 Secondary · Reporting Duration: >50% from baseline, and to a level < 1000 mg/gm, at six months

<1.0 ml/min/year drop in eGFR from baseline to six months
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
>30% from baseline at six months
To assess the efficacy of SQ BMT in combination with RAAS inhibition therapy to achieve complete remission.
>50% from baseline, and to a level < 1000 mg/gm, at six months
To evaluate the efficacy of SQ BMT in combination with RAAS inhibition therapy to achieve partial remission.
Baseline to after six months of combined therapy (RAAS inhibition therapy plus BMT).
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.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Intravenous immune globulin G
1
ASP9801
2
BLU-263

Trial Design

1 Treatment Group

Subcutaneous Bremelanotide
1 of 1

Experimental Treatment

45 Total Participants · 1 Treatment Group

Primary Treatment: Subcutaneous Bremelanotide · No Placebo Group · Phase 2

Subcutaneous BremelanotideExperimental Group · 2 Interventions: Bremelanotide, RAAS inhibition therapy · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bremelanotide
2014
Completed Phase 3
~1670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: >50% from baseline, and to a level < 1000 mg/gm, at six months

Who is running the clinical trial?

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

Eligibility Criteria

Age 18 - 80 · All Participants · 19 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you need medication to control your blood pressure during the study, you will use drugs that do not affect the amount of protein in your urine.
If you have diabetes, your insulin and other medications may need to be adjusted to manage your blood sugar levels during the study.
The study is interested in examining the effects of the medication on people with diabetic retinopathy and diabetic peripheral neuropathy, and those with these conditions are encouraged to participate.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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