Recruiting
Phase 1
Phase 2

Mycophenolate Mofetil

Sponsor:

Augusta University

Code:

NCT02432339

Conditions

Psychological Stress

Hypertension, Renal

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

mycophenolate mofetil (MMF)

Placebo

Study Details

Brief summary:

The purpose of this study is to determine if stopping the stress induced increase in inflammation will prevent sodium retention which in turn increases blood pressure. Each subject will test two separate times. One week, they will be taking a daily dose of mycophenolate mofetil (MMF), the other week they will be taking a placebo.

Conditions

Psychological Stress

Hypertension, Renal

Study ID

NCT02432339

Start date

Apr 22, 2014

Status verified date

Jun, 2019

Completion date

Nov 30, 2019

Anticipated

Primary completion date

Nov, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • African American
  • Not pregnant or breastfeeding
  • Does not have high blood pressure
  • Currently not taking any medications that may effect blood pressure

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Has High Blood pressure
  • Taking medication that may effect blood pressure
  • Failed Screening blood sample lab results - reviewed by study designated doctor

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: mycophenolate mofetil (MMF)

Mycophenolate Mofetil (MMF) 500 mg tablet twice a day for 7 1/2 days.

placebo comparator: Placebo

Placebo (sugar pill) in the same size capsule that the MMF is used in - twice a day for 7 1/2 days.

Interventions

mycophenolate mofetil (MMF)

an immunosuppressant - 500 mgs twice a day for 7 1/2 days - in capsule form

Placebo

a sugar pill - 500 mgs twice a day for 7 1/2 days - in the same capsule form as the MMF

Primary outcome measure

  • Urinary sodium excretion rate [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Sandra Young-Mayes, BS

7067217698syoungmayes@augusta.edu

Michelle Brown, MS

7067219893mibrown1@augusta.edu

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Sandra Young-Mayes, BS

706-721-7698syoungmayes@augusta.edu

Michelle Brown, MS

7067219893mibrown1@augusta.edu

Principal Investigator:

Gregory A Harshfield, PhD

More Information

Sponsor

Augusta University

Last update posted

Jun 20, 2019

Last verified

Jun, 2019

Keywords

  • immune system
  • RENIN-ANGIOTENSIN SYSTEM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Augusta University on 2019-06-20.