Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease

Completed · Phase 2/Phase 3

Conditions studied: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

In brief

The purpose of this study is to learn if dietary habits can affect vasopressin secretion in patients with autosomal dominant polycystic kidney disease. Vasopressin increases the growth of kidney cysts and accelerates disease progression. Understanding how to control secretion of this hormone based on dietary habits may help to develop treatments to control this disease. The study will include about 60 patients from Tufts Medical Center. The study will last for 2 weeks. Blood and urine tests will be done 3 times during the study period. Subjects will be randomly assigned (by chance like flipping a coin), to one of two study groups. Group 1 will be given instructions to adjust their diet. This will include adjusting the amount of water, protein, and salt intake. Group 2 will have no adjustment of diet or water. The project has tremendous public health relevance, given the large numbers of people affected by autosomal dominant polycystic kidney disease and the substantial impact of the disease on morbidity, mortality, hospitalizations,dialysis or transplant, and societal costs of caring for those patients.

Key facts

Study ID

NCT02225860

Run by

Tufts Medical Center

People needed

34

Starts

2014-05-01

Expected to finish

2016-02-01

Last updated by the study team

2017-03-30

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 to 60 years of age, who have ADPKD with an estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73m2 or above

You may not qualify if…

• Patients on chronic use of medications known to affect AVP secretion (Serotonin Specific Reuptake inhibitors (SSRI), Opioids, Tricyclic Antidepressants (TCA) and Tolvaptan)
• History of diseases influencing renal concentration capacity, such as, diabetes insipidus, adrenal or thyroid deficiencies, present or prior use of lithium, or kidney diseases other than ADPKD.
• Baseline hyponatremia (Na below 135 mEq/l)
• Inability to comply with dietary or fluid requirements
• Have physical or cognitive impairments which prevent participation
• Pregnant women

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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