Trial · NCT01438710
Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
NCT01438710, Phase 3, Completed, Asahi Kasei Therapeutics, Inc.; results first posted 2015-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO). Trials, record NCT01438710. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01438710
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
- NCT number
- NCT01438710
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 44 participants, actual
- Lead sponsor
- Asahi Kasei Therapeutics, Inc.
- Conditions
- Renal Failure, Tremors
- Interventions
- Prograf, LCP-Tacro
- First posted
- 2011-09-22
- Last updated
- 2015-10-01
- Results first posted
- 2015-05-08
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro. | 14 days | The primary efficacy endpoint is the mean change from baseline (ie Day 7) in the Fahn-Tolosa-Marin Clinical Rating Scale (FTM) for overall tremor score 7 days after (ie, Day 14) LCP-Tacro conversion. The overall FTM score was 0 to 100 where higher scores denoted worst/more severe tremor. Below the mean total score and standard deviation for each treatment is given in addition to the mean change. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro. | 14 days | Of the 40 patients who completed the study period, 38 patients were evaluable for efficacy evaluation and included in the modified intention to treat (mITT) population.~The outcome measure is given as total score below. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro. | LCP-Tacro | Total score day 7 (Prograf) | 25.30 | Standard Deviation 9.472 | units on a scale |
| Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro. | LCP-Tacro | Total score day 14 (LCP-Tacro) | 19.96 | Standard Deviation 7.613 | units on a scale |
| Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro. | LCP-Tacro | Mean change | -5.35 | Standard Deviation 7.501 | units on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Week of Treatment | STARTED | LCP-Tacro | 0 | |
| First Week of Treatment | STARTED | Prograf | 44 | |
| First Week of Treatment | COMPLETED | LCP-Tacro | 0 | |
| First Week of Treatment | COMPLETED | Prograf | 41 | |
| First Week of Treatment | NOT COMPLETED | LCP-Tacro | 0 | |
| First Week of Treatment | NOT COMPLETED | Prograf | 3 | |
| Second Week of Treatment | STARTED | LCP-Tacro | 41 | |
| Second Week of Treatment | STARTED | Prograf | 0 | |
| Second Week of Treatment | COMPLETED | LCP-Tacro | 40 | |
| Second Week of Treatment | COMPLETED | Prograf | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events10
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 | Nausea | Gastrointestinal disorders | LCP-Tacro | 2 | 41 | 2 |
| other | Nausea | Gastrointestinal disorders | Prograf | 0 | 44 | 0 |
| other | Oedema peripheral | General disorders | LCP-Tacro | 0 | 41 | 0 |
| other | Oedema peripheral | General disorders | Prograf | 3 | 44 | 3 |
| other | Cardiac Murmur | Investigations | LCP-Tacro | 0 | 41 | 0 |
| other | Cardiac Murmur | Investigations | Prograf | 2 | 44 | 2 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | LCP-Tacro | 0 | 41 | 0 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Prograf | 2 | 44 | 2 |
| serious | Incision Site Cellulitis | Infections and infestations | LCP-Tacro | 0 | 41 | 0 |
| serious | Incision Site Cellulitis | Infections and infestations | Prograf | 1 | 44 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LCP-Tacro | ||
| Total, all-cause mortality | Prograf | ||
| Total, other adverse events | LCP-Tacro | 2 | 41 |
| Total, other adverse events | Prograf | 7 | 44 |
| Total, serious adverse events | LCP-Tacro | 0 | 41 |
| Total, serious adverse events | Prograf | 1 | 44 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| LCP-Tacro vs Prograf: serious adverse events |
Source Trial comparisons
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/NCT01438710
GET https://conductscience.org/api/trials/v1/NCT01438710/registered