Effects of an Immunosuppressant Mycophenolate Mofetil or MMF on the Urinary Sodium Excretion Response to Mental Stress (MMF)
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|ClinicalTrials.gov Identifier: NCT02432339|
Recruitment Status : Recruiting
First Posted : May 4, 2015
Last Update Posted : June 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psychological Stress Hypertension, Renal||Drug: mycophenolate mofetil (MMF) Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
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
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02432339
|Contact: Sandra Young-Mayes, BSemail@example.com|
|Contact: Michelle Brown, MSfirstname.lastname@example.org|
|United States, Georgia|
|Augusta, Georgia, United States, 30912|
|Contact: Sandra Young-Mayes, BS 706-721-7698 email@example.com|
|Contact: Michelle Brown, MS 7067219893 firstname.lastname@example.org|
|Principal Investigator: Gregory A Harshfield, PhD|
|Principal Investigator:||Gregory A Harshfield, PhD||Augusta University|