Trial Outcomes & Findings for Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease (NCT NCT02225860)

Results Overview

The copeptin level will reflect the combined effect of low osmolar diet and adjusted water intake at week 2

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

34 participants

Primary outcome timeframe

Baseline to week 2

Results posted on

2017-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Diet and Water Adjustment Reduction in dietary salt and protein intake Diet and water adjustment	Control Continue with usual diet
Overall Study STARTED	17	17
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diet and Water Adjustment n=17 Participants Reduction in dietary salt and protein intake Diet and water adjustment	Control n=17 Participants Continue with usual diet	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=99 Participants	17 Participants n=107 Participants	34 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	14 Participants n=99 Participants	14 Participants n=107 Participants	28 Participants n=206 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Region of Enrollment United States	17 participants n=99 Participants	17 participants n=107 Participants	34 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline to week 2

The copeptin level will reflect the combined effect of low osmolar diet and adjusted water intake at week 2

Outcome measures

Outcome measures
Measure	Diet and Water Adjustment n=17 Participants Reduction in dietary salt and protein intake Diet and water adjustment	Control n=17 Participants Continue with usual diet
Change in Mean Serum Copeptin From Baseline (a Reflection of Endogenous Vasopressin Production) at Week 2	-0.86 pmole/L Standard Deviation 1.3	0.39 pmole/L Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline to week 2

Total daily urinary solutes (this will serve as a surrogate for diet adherence and is known to be associated with lower vasopressin secretion). Total daily solutes is the total amount of osmoles detected in 24 hours urine collection.

Outcome measures

Outcome measures
Measure	Diet and Water Adjustment n=17 Participants Reduction in dietary salt and protein intake Diet and water adjustment	Control n=17 Participants Continue with usual diet
Change in Total Daily Urinary Solutes From Baseline to Week 2	-120 mOsm/Day Standard Deviation 212	27 mOsm/Day Standard Deviation 79

SECONDARY outcome

Timeframe: baseline to week 1

Population: At week 1, there was a nonsignificant (t-test) increase in plasma copeptin to 7.1 ±5.6 in the low osmolar diet group and to 6.1 ±5.5 in the control group. The change in mean plasma copeptin level between baseline and week1 was not statistically significant between groups.

Mean serum copeptin level at week one which will reflect the effect of low osmolar diet alone.

Outcome measures

Outcome measures
Measure	Diet and Water Adjustment n=17 Participants Reduction in dietary salt and protein intake Diet and water adjustment	Control n=17 Participants Continue with usual diet
Change in Mean Serum Copeptin Level From Baseline to Week 1	0.9 pmol/L Standard Deviation 1.2	1.4 pmol/L Standard Deviation 1.3

Adverse Events

Diet and Water Adjustment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ronald D. Perrone

Tufts Medical Center

Phone: 6176362372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place