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Polycystic kidney disease (PKD) is a genetic disease that occurs in 1 in 500 individuals and leads to kidney failure in half of all affected. Currently, no treatments exist for PKD. PKD-affected kidney cells divide and multiply inappropriately, and form fluid-filled sacs called cysts. Kidney cysts continue to grow throughout life, destroying normal kidney tissue, leading to kidney failure. Based on evidence from basic science research it is believed that drinking high amounts of water can slow the abnormal cysts growth. This study aims to look at changes in urine composition with high water intake in PKD-affected persons compared to healthy individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polycystic Kidney Disease Patients | Other | Patients who present with polycystic kidney disease (PKD) |
|
| Healthy Patients | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water | Other | Participants will be first asked to drink 6 8-oz glasses of water over 2.5 hours on the first day, and then about 12 8-oz glasses of water over the course of the day for one week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urine cAMP Concentration and Urine Osmolality (UOsm) | Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours | pre- and post-water loading (2 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irina Barash, M.D. | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Langone Medical Center | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Polycystic Kidney Disease (PKD) Patients | Patients who present with polycystic kidney disease (PKD) |
| FG001 | Healthy Patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Polycystic Kidney Disease (PKD) Patients | |
| BG001 | Healthy Patients | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Urine cAMP Concentration and Urine Osmolality (UOsm) | Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours | Number of participants was deemed to be adequate for the purposes of this pilot study | Posted | Mean | Standard Error | fold change in cAMP/UOsm (umol/UOsm) | pre- and post-water loading (2 hours) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Polycystic Kidney Disease Patients | Patients with Autosomal Dominant Polycystic Kidney Disease |
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This was a very small study, so larger numbers are needed. Urine cAMP measurement as a surrogate of response to water treatment needs further validation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Irina Barash | New York University School of Medicine | 212.263.5851 | irina.barash@nyumc.org |
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| D007690 | Polycystic Kidney Diseases |
| ID | Term |
|---|---|
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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Total of all reporting groups
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Healthy Controls | Healthy Controls | 0 | 10 | 0 | 10 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |