Trial · NCT01410448
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | 3 months | The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | 12 months | The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario | 3 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Patient Survival Rate: Percentage of Deaths - Worst-case Scenario | 3 Months, 12 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario | 3 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario | 3 months, 12 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With BPAR - Worst-case Scenario | 3 Months, 12 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Delayed Graft Function (DGF) - | 3 Months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Duration of DGF | 3 months | Participants from the Intent-to-Treat (ITT) populations who required dialysis, 46 (23.83%) of the IE group and 60 (31.58%) of the DE group, were analyzed. The ITT population included all randomized participants who were treated. | Days | MEDIAN |
| SECONDARY | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT | baseline, 3 Months | Participants from the ITT, who had both baseline and month 3 measurements, were included in the analysis for the month 3 time point. The ITT population included all randomized participants who were treated. | mL/min | MEAN |
| SECONDARY | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - Modified ITT | baseline, 12 months | Participants from the modified ITT, who had both baseline and month 12 measurements, were included in the analysis for the month 12 time point. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant. | mL/min | MEAN |
| SECONDARY | Change From Baseline in Serum Creatinine - ITT | baseline, 3 months | Participants from the ITT, who had both baseline and the post-baseline measurement for a given post-baseline time point, were included in the analysis for that post-baseline time point. The ITT population included all randomized participants who were treated. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Serum Creatinine - Modified ITT | baseline, 12 months | Participants from the modified ITT, who had both baseline and month 12 measurements, were included in the analysis for the month 12 time point. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant. | mg/dL | MEAN |
| SECONDARY | Percentage of Participants With Proteinuria | 3 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Acute Rejection (AR) | 12 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a New Onset of Malignancy | 12 months | Participants from the modified ITT, who had values at 12 months, were analyzed. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a New Onset of Diabetes | 12 months | Participants from the modified ITT, who had values at 12 months, were analyzed. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant. | Percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01410448/outcomes