Trial · NCT01120028
Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy
NCT01120028, Phase 2, Phase 3, Completed, University of Oxford; results first posted 2019-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy. Trials, record NCT01120028. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01120028
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy
- NCT number
- NCT01120028
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 852 participants, actual
- Lead sponsor
- University of Oxford
- Conditions
- Kidney Transplantation
- Interventions
- Alemtuzumab, Basiliximab, Sirolimus, Tacrolimus
- First posted
- 2010-05-10
- Last updated
- 2020-04-02
- Other registries' IDs
- eudract:2008-008553-27, isrctn:ISRCTN88894088
- Results first posted
- 2019-10-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy | 6 months post-transplantation | Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus)) |
| Primary | Graft Function (at 18-months After Randomization to Maintenance Therapy) | 2 years post-transplantation | Estimated glomerular filtration rate (estimated using MDRD formula) at 18-months after maintenance therapy randomization to either Sirolimus or Tacrolimus. |
| Secondary | Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy) | 6 months post-transplantation | Return to dialysis or re-transplantation by 6-months after randomization to induction therapy. |
| Secondary | Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy) | 2 years post-transplantation | Return to dialysis or re-transplantation by 18-months after randomization to maintenance therapy. |
| Secondary | Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy) | 6-months post-transplantation | Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported within Period 1 (randomization to induction therapy of either Alemtuzumab (Campath-1H) and Tacrolimus, or Basiliximab and Tacrolimus). |
| Secondary | Number of Participants With Serious Infection (at 18-months After Randomization to Maintenance Therapy) | 2 years post-transplantation | Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus). |
| Secondary | Number of Participants With Cancer (at 18-months After Randomization to Maintenance Therapy) | 2 years post-transplantation | Occurrence of any cancer reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus). |
| Secondary | Number of Participants With Major Vascular Event (at 18-months After Randomization to Maintenance Therapy) | 2 years post-transplantation | Composite of non-fatal myocardial infarction, non-fatal stroke, cardiovascular death or arterial revascularization |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy | 6 months post-transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Graft Function (at 18-months After Randomization to Maintenance Therapy) | 2 years post-transplantation | mL/min/1.73m² | MEAN | |
| SECONDARY | Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy) | 6 months post-transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy) | 2 years post-transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy) | 6-months post-transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Serious Infection (at 18-months After Randomization to Maintenance Therapy) | 2 years post-transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Cancer (at 18-months After Randomization to Maintenance Therapy) | 2 years post-transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Major Vascular Event (at 18-months After Randomization to Maintenance Therapy) | 2 years post-transplantation | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy | Period 1: Alemtuzumab/Tacrolimus | 31 | Participants | ||
| Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy | Period 1: Basiliximab/Tacrolimus | 68 | Participants | ||
| Graft Function (at 18-months After Randomization to Maintenance Therapy) | Period 2: Sirolimus | 53.7 | Standard Error 0.9 | mL/min/1.73m² | |
| Graft Function (at 18-months After Randomization to Maintenance Therapy) | Period 2: Tacrolimus | 54.6 | Standard Error 0.9 | mL/min/1.73m² | |
| Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy) | Period 1: Alemtuzumab/Tacrolimus | 16 | Participants | ||
| Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy) | Period 1: Basiliximab/Tacrolimus | 13 | Participants | ||
| Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy) | Period 2: Sirolimus | 8 | Participants | ||
| Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy) | Period 2: Tacrolimus | 4 | Participants | ||
| Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy) | Period 1: Campath 1H/Tacrolimus | 135 | Participants | ||
| Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy) | Period 1: Basiliximab/Tacrolimus | 136 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Alemtuzumab or Basiliximab | STARTED | Period 1: Alemtuzumab/Tacrolimus | 426 | |
| Period 1: Alemtuzumab or Basiliximab | STARTED | Period 1: Basiliximab/Tacrolimus | 426 | |
| Period 1: Alemtuzumab or Basiliximab | STARTED | Period 2: Sirolimus | 0 | |
| Period 1: Alemtuzumab or Basiliximab | STARTED | Period 2: Tacrolimus | 0 | |
| Period 1: Alemtuzumab or Basiliximab | COMPLETED | Period 1: Alemtuzumab/Tacrolimus | 412 | |
| Period 1: Alemtuzumab or Basiliximab | COMPLETED | Period 1: Basiliximab/Tacrolimus | 403 | |
| Period 1: Alemtuzumab or Basiliximab | COMPLETED | Period 2: Sirolimus | 0 | |
| Period 1: Alemtuzumab or Basiliximab | COMPLETED | Period 2: Tacrolimus | 0 | |
| Period 1: Alemtuzumab or Basiliximab | NOT COMPLETED | Period 1: Alemtuzumab/Tacrolimus | 14 | |
| Period 1: Alemtuzumab or Basiliximab | NOT COMPLETED | Period 1: Basiliximab/Tacrolimus | 23 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events104
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 |
|---|---|---|---|---|---|---|
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Period 1: Alemtuzumab/Tacrolimus | 26 | 426 | |
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Period 1: Basiliximab/Tacrolimus | 15 | 426 | |
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Period 2: Sirolimus | 3 | 197 | |
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Period 2: Tacrolimus | 7 | 197 | |
| serious | Cardiac disorders | Cardiac disorders | Period 1: Alemtuzumab/Tacrolimus | 14 | 426 | |
| serious | Cardiac disorders | Cardiac disorders | Period 1: Basiliximab/Tacrolimus | 15 | 426 | |
| serious | Cardiac disorders | Cardiac disorders | Period 2: Sirolimus | 10 | 197 | |
| serious | Cardiac disorders | Cardiac disorders | Period 2: Tacrolimus | 3 | 197 | |
| serious | Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | Period 1: Alemtuzumab/Tacrolimus | 0 | 426 | |
| serious | Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | Period 1: Basiliximab/Tacrolimus | 0 | 426 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Period 1: Alemtuzumab/Tacrolimus | 11 | 426 |
| Total, all-cause mortality | Period 1: Basiliximab/Tacrolimus | 6 | 426 |
| Total, all-cause mortality | Period 2: Sirolimus | 11 | 197 |
| Total, all-cause mortality | Period 2: Tacrolimus | 9 | 197 |
| Total, other adverse events | Period 1: Alemtuzumab/Tacrolimus | 0 | 0 |
| Total, other adverse events | Period 1: Basiliximab/Tacrolimus | 0 | 0 |
| Total, other adverse events | Period 2: Sirolimus | 0 | 0 |
| Total, other adverse events | Period 2: Tacrolimus | 0 | 0 |
| Total, serious adverse events | Period 1: Alemtuzumab/Tacrolimus | 341 | 426 |
| Total, serious adverse events | Period 1: Basiliximab/Tacrolimus | 354 | 426 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Period 1: Campath 1H/Tacrolimus vs Period 1: Basiliximab/Tacrolimus: Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy) | Trial comparisons |
| Period 2: Sirolimus vs Period 2: Tacrolimus: Number of Participants With Major Vascular Event (at 18-months After Randomization to Maintenance Therapy) | Trial comparisons |
| Period 2: Sirolimus vs Period 2: Tacrolimus: Number of Participants With Serious Infection (at 18-months After Randomization to Maintenance Therapy) | Trial comparisons |
| Period 1: Alemtuzumab/Tacrolimus vs Period 1: Basiliximab/Tacrolimus: Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy) | Trial comparisons |
| Period 2: Sirolimus vs Period 2: Tacrolimus: Number of Participants With Cancer (at 18-months After Randomization to Maintenance Therapy) | Trial comparisons |
| Period 1: Alemtuzumab/Tacrolimus vs Period 1: Basiliximab/Tacrolimus: Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy | Trial comparisons |
| Period 2: Sirolimus vs Period 2: Tacrolimus: Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy) | 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/NCT01120028
GET https://conductscience.org/api/trials/v1/NCT01120028/flow?page=2