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In this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM). This relatively small well-tolerated dose is likely to persistently increase urine volume and reduce urine supersaturation and to be well tolerated by patients with kidney stone disease and normal renal function (see below). The twice-daily (8 AM and 4 PM) regimen is designed to produce a maximal AVP inhibition on waking with a gradual fall-off of effect during the night. To this end, a higher dose is used in the morning, with a lower dose in the afternoon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolvaptan first, then Placebo | Experimental | Tolvaptan twice daily in first intervention period and placebo twice daily in second intervention period. (after washout period) |
|
| Placebo first, then Tolvaptan | Experimental | Placebo twice daily in first intervention period and Tolvaptan twice daily in second intervention period. (after washout period) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in urinary calcium oxalate supersaturation (SS) | Calcium oxalate (CaOx) SS is primary endpoint for CaOx stone formers. | Baseline to 3 weeks |
| Change in Calcium phosphate SS | Calcium phosphate (CaPhos) SS is the primary endpoint for CaPhos stone formers. | Baseline to three weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Lieske, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| C563477 | Nephrolithiasis, Calcium Oxalate |
| D053040 | Nephrolithiasis |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo | Drug | Patients will receive daily dose at 8 AM and at 4 PM. |
|
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |