MANP in African Americans With Hypertension

NCT04542681 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: IRB # 17-007947
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the cardiovascular properties of MANP in AA with Hypertension

Conditions

Hypertension, Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Blood Pressure

  The primary outcome is change in blood pressure 12 hours after MANP or placebo administration compared to the baseline blood pressure. Blood pressure will be measured by an automated arm blood pressure cuff. The unit of measurement is mm Hg. Time frame = 12 hours.

  12 hours

Secondary Outcomes (4)

• Urinary cGMP excretion

  12 hours

• Urinary sodium excretion

  12 hours

• Glomerular filtration rate

  12 hours

• Plasma aldosterone

  12 hours

Study Arms (3)

Placebo - 1st Cycle

PLACEBO COMPARATOR

Subjects will receive a single SQ injection of placebo (0.9% normal saline) (n=10)

Drug: Placebo - 1st Cycle

MANP - 1st Cycle

ACTIVE COMPARATOR

Subjects will receive a single SQ injection of 2.5 μg/kg MANP (n=10)

Drug: MANP - 1st Cycle

MANP - 2nd Cycle

ACTIVE COMPARATOR

Subjects will receive a single SQ injection of 5 μg/Kg MANP (n=10)

Drug: MANP - 2nd Cycle

Interventions

Placebo - 1st Cycle DRUG

Subjects will receive a single SQ injection of placebo/normal saline

Also known as: 0.9% Normal Saline

Placebo - 1st Cycle

MANP - 1st Cycle DRUG

Subjects will receive a single SQ injection of MANP at a concentration of 2.5 μg/kg

Also known as: Mutant ANP

MANP - 1st Cycle

MANP - 2nd Cycle DRUG

Subjects will receive a single SQ injection of MANP 5 μg/kg concentration.

Also known as: Mutant ANP

MANP - 2nd Cycle

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertension, defined as a mean supine BP equal to or greater than 140 mmHg and taking at least one standard of care therapies (including a diuretic, angiotensin converting enzyme inhibitor or angiotensin receptor blocker and a calcium channel blocker);
• MDRD estimated GFR \> 30 mL/min to be calculated at the screening visit by available serum creatinine
• Male or female African Americans
• Have a body mass index (BMI) within the range of 18-40 kg/m2;
• Be able to communicate effectively with the study personnel
• Be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication.

You may not qualify if:

• Known hypersensitivity or allergy to MANP or other NPs;
• Women of child bearing age
• Having received any investigational drug or device within 30 days prior to entry into the study; 4) A history (within the last 2 years) of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction;
• A history of difficulty with donating blood or donated blood or blood products within 45 days prior to enrollment;
• Clinically significant new illness in the 1 month before screening in the opinion of the investigator;
• History of severe allergies;
• History of CAD, CVD or syncope;
• History of epilepsy or other seizure disorder;
• History of organ transplantation;
• Malignancy within 5 years;
• Clinically significant intrinsic renal disease, renal artery stenosis, or history of fibromuscular dysplasia of the renal arteries and;
• Consumption of a phosphodiesterase-5 inhibitor.
• Known adrenal insufficiency
• Subjects with orthostatic hypotension at the screening visit, defined as a decrease in systolic BP of \>20 mmHg or a decrease in diastolic BP of \>10 mmHg within three minutes of standing when compared with blood pressure from the sitting position.
• Subjects with a systolic BP \>180 mmHg or a diastolic BP \>100 mmHg while sitting

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Paul M McKie, M.D.

  Mayo Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: The study is designed in 2 cycles. The first cycle subjects will receive Placebo (n=10) or MANP 2.5 ug/kg (n=20). In the second cycle subjects will receive MANP 5 ug/kg/ (n=10).

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: September 9, 2020
• Study Start: May 1, 2018
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

US (1)