|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02225860 |
|
Date of registration:
|
20/08/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease
|
|
Scientific title:
|
Low Osmolar Diet and Adjusted Water Intake for Vasopressin Suppression in ADPKD |
|
Date of first enrolment:
|
May 2014 |
|
Target sample size:
|
34 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02225860 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Osama Amro, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Tufts Medical Center |
|
|
Name:
|
Ronald Perrone, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Tufts Medical Center |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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
Exclusion Criteria:
1. Patients on chronic use of medications known to affect AVP secretion (Serotonin
Specific Reuptake inhibitors (SSRI), Opioids, Tricyclic Antidepressants (TCA) and
Tolvaptan)
2. 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.
3. Baseline hyponatremia (Na below 135 mEq/l)
4. Inability to comply with dietary or fluid requirements
5. Have physical or cognitive impairments which prevent participation
6. Pregnant women
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
|
|
Intervention(s)
|
|
Behavioral: Diet and water adjustment
|
|
Primary Outcome(s)
|
|
Change in Mean Serum Copeptin From Baseline (a Reflection of Endogenous Vasopressin Production) at Week 2
[Time Frame: Baseline to week 2]
|
|
Secondary Outcome(s)
|
|
Change in Total Daily Urinary Solutes From Baseline to Week 2
[Time Frame: Baseline to week 2]
|
|
Change in Mean Serum Copeptin Level From Baseline to Week 1
[Time Frame: baseline to week 1]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|