Trial · NCT02538016
TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study
NCT02538016, Not applicable, Completed, Caleb Nelson; results first posted 2020-06-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study. Trials, record NCT02538016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02538016
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study
- NCT number
- NCT02538016
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 4 participants, actual
- Lead sponsor
- Caleb Nelson
- Conditions
- Cystinuria
- Interventions
- Tolvaptan
- First posted
- 2015-09-02
- Last updated
- 2020-07-10
- Results first posted
- 2020-06-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urinary Cystine Supersaturation (mg/L) at High Dose (Day7-8) | 23 days | The primary outcome was urinary cystine supersaturation as measured by "cystine capacity". This proprietary test (Litholink Corp., Chicago IL) is reported as a value in mg/L above or below zero, with positive values indicating urine undersaturated with cystine, while negative values indicate that the urine is supersaturated with cystine. Four 24-hour urine samples were obtained during the study: one at baseline 3-6 days prior to the measurement, one on day 3-4 of the dosing period, one on day 7-8 of the dosing period, and one 3-6 days after the washout period. Each 24 hour urine sample was sent individually for analysis by Litholink Corp, which performs the cystine assays. |
| Secondary | Urine Osmolality at High Dose (Day 8) | 11 days | Secondary outcomes included serum sodium and other electrolyte levels. Serum electrolytes for each subject before, during, and after tolvaptan treatment (Sodium/Potassium/Chloride in mmol/L). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Urinary Cystine Supersaturation (mg/L) at High Dose (Day7-8) | 23 days | mg/L | MEAN | |
| SECONDARY | Urine Osmolality at High Dose (Day 8) | 11 days | mmol/L | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Urinary Cystine Supersaturation (mg/L) at High Dose (Day7-8) | Tolvaptan | 70 | Full Range -3 to 111 | mg/L | |
| Urine Osmolality at High Dose (Day 8) | Tolvaptan | Sodium | 141 | Full Range 139 to 142 | mmol/L |
| Urine Osmolality at High Dose (Day 8) | Tolvaptan | Potassium | 4.05 | Full Range 3.7 to 4.4 | mmol/L |
| Urine Osmolality at High Dose (Day 8) | Tolvaptan | Chloride | 102 | Full Range 101 to 103 | mmol/L |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tolvaptan | 4 | |
| Overall Study | COMPLETED | Tolvaptan | 4 | |
| Overall Study | NOT COMPLETED | Tolvaptan | 0 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Severe Thirst | Investigations | Tolvaptan | 4 | 4 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolvaptan | 0 | 4 |
| Total, other adverse events | Tolvaptan | 4 | 4 |
| Total, serious adverse events | Tolvaptan | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02538016
GET https://conductscience.org/api/trials/v1/NCT02538016/registered