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Effects of an Immunosuppressant Mycophenolate Mofetil or MMF on the Urinary Sodium Excretion Response to Mental Stress (MMF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02432339
Recruitment Status : Recruiting
First Posted : May 4, 2015
Last Update Posted : June 20, 2019
Information provided by (Responsible Party):
Gregory Harshfield, Augusta University

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.

Condition or disease Intervention/treatment Phase
Psychological Stress Hypertension, Renal Drug: mycophenolate mofetil (MMF) Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Comparing the Effects of an Immunosuppressant (Mycophenolate Mofetil or MMF) on the Urinary Sodium Excretion Response to Mental Stress in a Crossover Design (MMF)
Actual Study Start Date : April 22, 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 30, 2019

Arm Intervention/treatment
Experimental: mycophenolate mofetil (MMF)
Mycophenolate Mofetil (MMF) 500 mg tablet twice a day for 7 1/2 days.
Drug: mycophenolate mofetil (MMF)
an immunosuppressant - 500 mgs twice a day for 7 1/2 days - in capsule form
Other Name: CellCept Chemical formula: C23H31NO7 Drugbank ID: DB00688

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.
Drug: Placebo
a sugar pill - 500 mgs twice a day for 7 1/2 days - in the same capsule form as the MMF
Other Name: a sugar pill

Primary Outcome Measures :
  1. Urinary sodium excretion rate [ Time Frame: 2 hours ]
    primary variable of interest is the difference in stress induced changes in sodium excretion between placebo and treatment conditions.

Secondary Outcome Measures :
  1. Hemodynamics- change in systolic blood pressure compared to changes in sodium excretion [ Time Frame: 2 hours ]
    measures of change in systolic blood pressure compared to changes in sodium excretion in treatment verses placebo.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02432339

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Contact: Sandra Young-Mayes, BS 7067217698
Contact: Michelle Brown, MS 7067219893

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United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Sandra Young-Mayes, BS    706-721-7698   
Contact: Michelle Brown, MS    7067219893   
Principal Investigator: Gregory A Harshfield, PhD         
Sponsors and Collaborators
Augusta University
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Principal Investigator: Gregory A Harshfield, PhD Augusta University

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Responsible Party: Gregory Harshfield, Director, Augusta University Identifier: NCT02432339    
Other Study ID Numbers: 611878
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The following avenues of dissemination will be used to share the research results:

Publications: Study results that are published will be made available in PubMed-cited journals and submitted to PubMed Central in a timely fashion. All data that involves human subjects will be de-identified and presented in a format that protects the identity and privacy of study participants. Publication of results in professional peer reviewed journals will be a priority. All publications will acknowledge the support of the NIH/NHLBI per notice of award guidelines. Every effort will be made to publish scientific results from this project in a timely manner.

Presentation at Scientific meetings: Abstracts will be submitted to the local, regional, and national association meetings such as annual meetings of the American Heart Association Council for High Blood Pressure Research, American Society of Hypertension, and American Society of Nephrology as well as Experimental Biology.

Supporting Materials: Study Protocol
Keywords provided by Gregory Harshfield, Augusta University:
immune system
Additional relevant MeSH terms:
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Mycophenolic Acid
Hypertension, Renal
Stress, Psychological
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs