Effects of an Immunosuppressant Mycophenolate Mofetil or MMF on the Urinary Sodium Excretion Response to Mental Stress
MMF
Comparing the Effects of an Immunosuppressant (Mycophenolate Mofetil or MMF) on the Urinary Sodium Excretion Response to Mental Stress in a Crossover Design (MMF)
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2014
CompletedFirst Submitted
Initial submission to the registry
April 17, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedJune 20, 2019
June 1, 2019
5.5 years
April 17, 2015
June 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary sodium excretion rate
primary variable of interest is the difference in stress induced changes in sodium excretion between placebo and treatment conditions.
2 hours
Secondary Outcomes (1)
Hemodynamics- change in systolic blood pressure compared to changes in sodium excretion
2 hours
Study Arms (2)
mycophenolate mofetil (MMF)
EXPERIMENTALMycophenolate Mofetil (MMF) 500 mg tablet twice a day for 7 1/2 days.
Placebo
PLACEBO COMPARATORPlacebo (sugar pill) in the same size capsule that the MMF is used in - twice a day for 7 1/2 days.
Interventions
an immunosuppressant - 500 mgs twice a day for 7 1/2 days - in capsule form
a sugar pill - 500 mgs twice a day for 7 1/2 days - in the same capsule form as the MMF
Eligibility Criteria
You may qualify if:
- African American
- Not pregnant or breastfeeding
- Does not have high blood pressure
- Currently not taking any medications that may effect blood pressure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Augusta University
Augusta, Georgia, 30912, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory A Harshfield, PhD
Augusta University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
April 17, 2015
First Posted
May 4, 2015
Study Start
April 22, 2014
Primary Completion
November 1, 2019
Study Completion
November 30, 2019
Last Updated
June 20, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
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.