Trial · NCT01062555
Calcineurin Inhibitor Sparing After Kidney Transplantation
NCT01062555, Phase 1, Phase 2, Completed, University of Minnesota; results first posted 2020-12-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Calcineurin Inhibitor Sparing After Kidney Transplantation. Trials, record NCT01062555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01062555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Calcineurin Inhibitor Sparing After Kidney Transplantation
- NCT number
- NCT01062555
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 527 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- CNI Side Effects
- Interventions
- Cyclosporine & Cellcept, Prograf & Cellcept, Low Dose CNI (Cyclosporine or FK) and Cellcept, Rapamune and Cellcept
- First posted
- 2010-02-04
- Last updated
- 2020-12-14
- Results first posted
- 2020-12-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: The Minimization of Negative Side Effects - Patient Survival | 6 months | The percentage of patients alive at 6 month post transplant. |
| Primary | Phase II: The Minimization of Negative Side Effects - Patient Survival | up to 7 years | The percentage of patients alive at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up. |
| Primary | Phase I: The Minimization of Negative Side Effects - Graft Survival | 6 months | Percent of participants at 6 months with a functioning graft (without graft failure). |
| Primary | Phase II: The Minimization of Negative Side Effects - Graft Survival | up to 7 years | The percentage of patients with a functioning graft (without graft failure) at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up. |
| Primary | Phase I: Acute Rejection-Free Survival | 6 months | Percent of participants at 6 months without acute rejection. |
| Primary | Phase II: Acute Rejection-Free Survival | up to 7 years | The percentage of patients without acute rejection at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I: The Minimization of Negative Side Effects - Patient Survival | 6 months | percentage of participants | NUMBER | |
| PRIMARY | Phase II: The Minimization of Negative Side Effects - Patient Survival | up to 7 years | percentage of participants | NUMBER | |
| PRIMARY | Phase I: The Minimization of Negative Side Effects - Graft Survival | 6 months | percentage of participants | NUMBER | |
| PRIMARY | Phase II: The Minimization of Negative Side Effects - Graft Survival | up to 7 years | percentage of participants | NUMBER | |
| PRIMARY | Phase I: Acute Rejection-Free Survival | 6 months | percentage of participants | NUMBER | |
| PRIMARY | Phase II: Acute Rejection-Free Survival | up to 7 years | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I: The Minimization of Negative Side Effects - Patient Survival | Phase I Arm 1 | 99 | percentage of participants | ||
| Phase I: The Minimization of Negative Side Effects - Patient Survival | Phase I Arm 2 | 98 | percentage of participants | ||
| Phase II: The Minimization of Negative Side Effects - Patient Survival | Phase II Arm 1 | 89 | percentage of participants | ||
| Phase II: The Minimization of Negative Side Effects - Patient Survival | Phase II Arm 2 | 85 | percentage of participants | ||
| Phase I: The Minimization of Negative Side Effects - Graft Survival | Phase I Arm 1 | 99 | percentage of participants | ||
| Phase I: The Minimization of Negative Side Effects - Graft Survival | Phase I Arm 2 | 99 | percentage of participants | ||
| Phase II: The Minimization of Negative Side Effects - Graft Survival | Phase II Arm 1 | 80 | percentage of participants | ||
| Phase II: The Minimization of Negative Side Effects - Graft Survival | Phase II Arm 2 | 78 | percentage of participants | ||
| Phase I: Acute Rejection-Free Survival | Phase I Arm 1 | 80 | percentage of participants | ||
| Phase I: Acute Rejection-Free Survival | Phase I Arm 2 | 85 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Phase I Arm 1 | 266 | |
| Phase 1 | STARTED | Phase I Arm 2 | 261 | |
| Phase 1 | STARTED | Phase II Arm 1 | 0 | |
| Phase 1 | STARTED | Phase II Arm 2 | 0 | |
| Phase 1 | COMPLETED | Phase I Arm 1 | 243 | |
| Phase 1 | COMPLETED | Phase I Arm 2 | 235 | |
| Phase 1 | COMPLETED | Phase II Arm 1 | 0 | |
| Phase 1 | COMPLETED | Phase II Arm 2 | 0 | |
| Phase 1 | NOT COMPLETED | Phase I Arm 1 | 23 | |
| Phase 1 | NOT COMPLETED | Phase I Arm 2 | 26 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I Arm 1 | 10 | 266 |
| Total, all-cause mortality | Phase I Arm 2 | 17 | 261 |
| Total, all-cause mortality | Phase II Arm 1 | 8 | 86 |
| Total, all-cause mortality | Phase II Arm 2 | 3 | 87 |
| Total, other adverse events | Phase I Arm 1 | 0 | 0 |
| Total, other adverse events | Phase I Arm 2 | 0 | 0 |
| Total, other adverse events | Phase II Arm 1 | 0 | 0 |
| Total, other adverse events | Phase II Arm 2 | 0 | 0 |
| Total, serious adverse events | Phase I Arm 1 | 0 | 266 |
| Total, serious adverse events | Phase I Arm 2 | 0 | 261 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT01062555
GET https://conductscience.org/api/trials/v1/NCT01062555/flow?page=2