Trial · NCT00064701
Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients
NCT00064701, Phase 3, Completed, Astellas Pharma Inc; results first posted 2013-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients. Trials, record NCT00064701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00064701
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients
- NCT number
- NCT00064701
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 668 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Kidney Transplantation
- Interventions
- Tacrolimus Modified Release (MR), Tacrolimus, cyclosporine microemulsion, mycophenolate mofetil
- First posted
- 2003-07-14
- Last updated
- 2013-12-05
- Results first posted
- 2013-09-26
- Limitations and caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Efficacy Failure | one year | Efficacy failure is defined as any participant who died, experienced a graft failure (permanent return to dialysis \[\> 30 days\] or retransplant), had a biopsy-confirmed (Banff Grade ≥ I) acute rejection (BCAR), or was lost to follow-up. Biopsies were graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel. |
| Secondary | Patient Survival at One Year | One year | Patient survival is defined as any participant who is known to be alive one year after the skin closure date. Participants who died or whose outcome was unknown at one year were considered to be non-survivors. |
| Secondary | Graft Survival at One Year | One year | Graft survival defined as any participant who did not meet the criteria for graft loss, where graft loss is defined as any re-transplant, permanent return to dialysis (\> 30 days), patient death, or participant whose outcome at one year was unknown. Participants were only counted once regardless of how many criteria were met. |
| Secondary | Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months | Six months and 12 months | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel. Acute rejection is defined as a grade ≥ I. |
| Secondary | Time to First Biopsy-confirmed Acute Rejection Episode | one year | Time to first biopsy-confirmed acute rejection episode defined as the number of days from skin closure (Day 0) to the date of biopsy. Rejection episodes were confirmed by biopsy by the clinical site pathologist and graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel. Acute rejection is defined as a grade ≥ I. |
| Secondary | Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection | one year | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Participants with histologically-proven Banff Grade II or III rejection or participants with steroid-resistant rejection were treated with anti-lymphocyte antibody treatment according to institutional practice. Biopsies were graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel. |
| Secondary | Severity of Acute Rejection | one year | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade IA: Significant interstitial infiltration and foci of moderate tubulitis; Grade IB: Significant interstitial infiltration and foci of severe tubulitis; Grade IIA: Mild to moderate intimal arteritis in at least 1 arterial cross section Grade IIB: Severe intimal arteritis comprising \>25% of the luminal area lost in at least 1 arterial cross section; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel. |
| Secondary | Number of Participants Experiencing Multiple Rejection Episodes | one year | This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated. |
| Secondary | Number of Participants With Clinically Treated Acute Rejection Episodes | one year | A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy. |
| Secondary | Number of Participants With Treatment Failure | one year | Treatment failure was defined as the discontinuation of randomized study drug for any reason. Participants who met the definition of treatment failure were to be followed throughout the 12-month treatment period. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Efficacy Failure | one year | The number of participants analyzed represents the full analysis set, defined as all randomized patients who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Patient Survival at One Year | One year | The number of participants analyzed represents the full analysis set. | percentage of participants | NUMBER |
| SECONDARY | Graft Survival at One Year | One year | The number of participants analyzed represents the full analysis set. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months | Six months and 12 months | The number of participants analyzed represents the full analysis set. | percentage of participants | NUMBER |
| SECONDARY | Time to First Biopsy-confirmed Acute Rejection Episode | one year | The number of participants analyzed represents the full analysis set. | days | MEDIAN |
| SECONDARY | Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection | one year | The number of participants analyzed represents the full analysis set. | participants | NUMBER |
| SECONDARY | Severity of Acute Rejection | one year | The number of participants analyzed represents the full analysis set with a biopsy-confirmed acute rejection episode during one year. | participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Multiple Rejection Episodes | one year | The number of participants analyzed represents the full analysis set. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Treated Acute Rejection Episodes | one year | The number of participants analyzed represents the full analysis set. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Failure | one year | The number of participants analyzed represents the full analysis set. | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Efficacy Failure | Tacrolimus | 15.1 | percentage of participants | ||
| Percentage of Participants With Efficacy Failure | Tacrolimus Modified Release | 14.0 | percentage of participants | ||
| Percentage of Participants With Efficacy Failure | Cyclosporine | 17.0 | percentage of participants | ||
| Patient Survival at One Year | Tacrolimus | 93.9 | percentage of participants | ||
| Patient Survival at One Year | Tacrolimus Modified Release | 97.2 | percentage of participants | ||
| Patient Survival at One Year | Cyclosporine | 97.2 | percentage of participants | ||
| Graft Survival at One Year | Tacrolimus | 91.5 | percentage of participants | ||
| Graft Survival at One Year | Tacrolimus Modified Release | 95.3 | percentage of participants | ||
| Graft Survival at One Year | Cyclosporine | 95.3 | percentage of participants | ||
| Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months | Tacrolimus | At 6 Months | 3.8 | percentage of participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| One Year Post-transplant | STARTED | Tacrolimus | 219 | |
| One Year Post-transplant | STARTED | Tacrolimus Modified Release | 226 | |
| One Year Post-transplant | STARTED | Cyclosporine | 223 | |
| One Year Post-transplant | Received Study Drug | Tacrolimus | 212 | |
| One Year Post-transplant | Received Study Drug | Tacrolimus Modified Release | 214 | |
| One Year Post-transplant | Received Study Drug | Cyclosporine | 212 | |
| One Year Post-transplant | COMPLETED | Tacrolimus | 179 | |
| One Year Post-transplant | COMPLETED | Tacrolimus Modified Release | 183 | |
| One Year Post-transplant | COMPLETED | Cyclosporine | 151 | |
| One Year Post-transplant | NOT COMPLETED | Tacrolimus | 40 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,758
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 | Diarrhoea | Gastrointestinal disorders | Tacrolimus | 91 | 212 | |
| other | Diarrhoea | Gastrointestinal disorders | Tacrolimus Modified Release | 94 | 214 | |
| other | Diarrhoea | Gastrointestinal disorders | Cyclosporine | 53 | 212 | |
| other | Constipation | Gastrointestinal disorders | Tacrolimus | 68 | 212 | |
| other | Constipation | Gastrointestinal disorders | Tacrolimus Modified Release | 85 | 214 | |
| other | Constipation | Gastrointestinal disorders | Cyclosporine | 82 | 212 | |
| other | Nausea | Gastrointestinal disorders | Tacrolimus | 71 | 212 | |
| other | Nausea | Gastrointestinal disorders | Tacrolimus Modified Release | 74 | 214 | |
| other | Nausea | Gastrointestinal disorders | Cyclosporine | 90 | 212 | |
| other | Vomiting | Gastrointestinal disorders | Tacrolimus | 49 | 212 |
1 to 10 of 1,758Source ClinicalTrials.gov
See all 1,758 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tacrolimus | ||
| Total, all-cause mortality | Tacrolimus Modified Release | ||
| Total, all-cause mortality | Cyclosporine | ||
| Total, other adverse events | Tacrolimus | 208 | 212 |
| Total, other adverse events | Tacrolimus Modified Release | 212 | 214 |
| Total, other adverse events | Cyclosporine | 208 | 212 |
| Total, serious adverse events | Tacrolimus | 148 | 212 |
| Total, serious adverse events | Tacrolimus Modified Release | 141 | 214 |
| Total, serious adverse events | Cyclosporine | 139 | 212 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17217442 | BACKGROUND |
Source PubMed
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/NCT00064701
GET https://conductscience.org/api/trials/v1/NCT00064701/results?page=2