Trial Outcomes & Findings for High Water Intake to Slow Progression of Polycystic Kidney Disease (NCT NCT00784030)
NCT ID: NCT00784030
Last Updated: 2016-04-06
Results Overview
Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
pre- and post-water loading (2 hours)
Results posted on
2016-04-06
Participant Flow
Participant milestones
| Measure |
Polycystic Kidney Disease (PKD) Patients
Patients who present with polycystic kidney disease (PKD)
|
Healthy Patients
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Water Intake to Slow Progression of Polycystic Kidney Disease
Baseline characteristics by cohort
| Measure |
Polycystic Kidney Disease (PKD) Patients
n=13 Participants
|
Healthy Patients
n=10 Participants
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre- and post-water loading (2 hours)Population: Number of participants was deemed to be adequate for the purposes of this pilot study
Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours
Outcome measures
| Measure |
Polycystic Kidney Disease Patients
n=13 Participants
Patients with Autosomal Dominant Polycystic Kidney Disease
|
Healthy Controls
n=10 Participants
Healthy Controls
|
|---|---|---|
|
Change in Urine cAMP Concentration and Urine Osmolality (UOsm)
|
-2.6 fold change in cAMP/UOsm (umol/UOsm)
Standard Error 0.2
|
-2.0 fold change in cAMP/UOsm (umol/UOsm)
Standard Error 0.1
|
Adverse Events
Polycystic Kidney Disease Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
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
Dr. Irina Barash
New York University School of Medicine
Phone: 212.263.5851
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place