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This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.
Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in March 2014. This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water Load Group | Water load group: 2.5 ~ 3 L water intake daily for 12 months (50ml/Kg body weight/day). When large amount water intake is not sustainable, patients can reduce the amount of water intake to the levels as much as large he or she can sustain. | ||
| Non-Water Loaded Group | Non-water load group: The patients are free to access water intake, as they like. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total kidney volume (TKV) measured by magnetic resonance imaging (MRI). | The relationship between urine volume (and urine osmolality) and change of TKV. TKV slopes are compared between pre-study and study period. | One year (12 months) and pre-study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration rate (GFR) estimated by plasma creatinine and cystatin C. | The relationship between urine volume (and urine osmolality) and change of GFR. | One year (12 months) |
| Plasma arginine vasopressin (AVP, Copeptin) level. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients who visit Kyorin University Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Eiji Higashihara, M.D. | Kyorin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Kyorin University Hospital | Mitaka | Tokyo | 181-8611 | Japan |
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| D018450 | Disease Progression |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Urine
The relationship between urine volume (osmolality) and plasma AVP.
| 4-8-12 months |
| Quality of life (QOL) questionnaire. | The relationship between QOL and urine volume. | 4-8-12 months |
| D052776 |
| Female Urogenital Diseases |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |