Trial · NCT00807144
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
NCT00807144, Phase 4, Completed, Imperial College Healthcare NHS Trust; results first posted 2021-08-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation. Trials, record NCT00807144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00807144
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
- NCT number
- NCT00807144
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 102 participants, actual
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Conditions
- End-stage Renal Failure, Graft Rejection
- Interventions
- Tacrolimus (Kidney transplant maintenance immunosuppression), Kidney transplant maintenance immunosuppression
- First posted
- 2008-12-11
- Last updated
- 2021-08-27
- Other registries' IDs
- eudract:2008-000889-22
- Results first posted
- 2021-08-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Survival With a Functioning Graft | One year post kidney transplantation | |
| Secondary | Rejection-free Patient Survival With a Functioning Graft | One and two years post kidney transplantation | |
| Secondary | Patient-reported Quality of Life, and Medication Adherence | 3,6,& 12 months post kidney transplant |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient Survival With a Functioning Graft | One year post kidney transplantation | percent of participants | NUMBER | |
| SECONDARY | Rejection-free Patient Survival With a Functioning Graft | One and two years post kidney transplantation | percent of participants | NUMBER | |
| SECONDARY | Patient-reported Quality of Life, and Medication Adherence | 3,6,& 12 months post kidney transplant | Data not collected |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Survival With a Functioning Graft | Extended Release Tacrolimus | 92.3 | percent of participants | ||
| Patient Survival With a Functioning Graft | Standard Release Tacrolimus | 96 | percent of participants | ||
| Rejection-free Patient Survival With a Functioning Graft | Extended Release Tacrolimus | year 1 | 86 | percent of participants | |
| Rejection-free Patient Survival With a Functioning Graft | Standard Release Tacrolimus | year 1 | 84 | percent of participants | |
| Rejection-free Patient Survival With a Functioning Graft | Extended Release Tacrolimus | year 2 | 83.4 | percent of participants | |
| Rejection-free Patient Survival With a Functioning Graft | Standard Release Tacrolimus | year 2 | 80.1 | percent of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Extended Release Tacrolimus | 52 | |
| Overall Study | STARTED | Standard Release Tacrolimus | 50 | |
| Overall Study | COMPLETED | Extended Release Tacrolimus | 52 | |
| Overall Study | COMPLETED | Standard Release Tacrolimus | 49 | |
| Overall Study | NOT COMPLETED | Extended Release Tacrolimus | 0 | |
| Overall Study | NOT COMPLETED | Standard Release Tacrolimus | 1 |
Source ClinicalTrials.gov
Adverse events4
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 | Any rejection symptom | General disorders | Extended Release Tacrolimus | 8 | 52 | 8 |
| other | Any rejection symptom | General disorders | Standard Release Tacrolimus | 9 | 50 | 9 |
| serious | Liver failure | Hepatobiliary disorders | Extended Release Tacrolimus | 0 | 52 | 0 |
| serious | Liver failure | Hepatobiliary disorders | Standard Release Tacrolimus | 1 | 50 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Extended Release Tacrolimus | 4 | 52 |
| Total, all-cause mortality | Standard Release Tacrolimus | 2 | 50 |
| Total, other adverse events | Extended Release Tacrolimus | 8 | 52 |
| Total, other adverse events | Standard Release Tacrolimus | 9 | 50 |
| Total, serious adverse events | Extended Release Tacrolimus | 0 | 52 |
| Total, serious adverse events | Standard Release Tacrolimus | 1 | 50 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Extended Release Tacrolimus vs Standard Release Tacrolimus: deaths from any cause | Trial comparisons |
| Extended Release Tacrolimus vs Standard Release Tacrolimus: serious adverse events | 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/NCT00807144
GET https://conductscience.org/api/trials/v1/NCT00807144/registered