Trial · NCT01410448
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | 3 months | The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence, or study discontinuation due to any reason. |
| Secondary | Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | 12 months | The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence or study discontinuation due to any reason for participants who did not complete the 12 month follow-up visit. |
| Secondary | Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario | 3 months | The percentage of participants who experienced treatment failure was assessed. Treatment failure was defined as the occurrence of at least one failure event among death, graft loss or biopsy-proven acute rejection (BPAR). In the worst-case scenario, treatment failure was identified in one of the following cases: occurrence of at least one treatment failure event or study discontinuation due to any reason. |
| Secondary | Patient Survival Rate: Percentage of Deaths - Worst-case Scenario | 3 Months, 12 months | The percentage of deaths was assessed. In the worst-case scenario, failure, i.e. death, was identified in one of the following cases: participant's death or study discontinuation due to any reason. |
| Secondary | Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario | 3 months | The percentage of participants who experienced death or graft loss was assessed. In the worst-case scenario, failure, i.e. participants death or graft loss, was identified in one of the following cases: occurrence of at least one failure event or study discontinuation due to any reason. |
| Secondary | Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario | 3 months, 12 months | The percentage of participants who experienced graft loss was assessed. In the worst-case scenario, failure, i.e. graft loss, was identified in one of the following cases: occurrence of graft loss or discontinuation due to any reason. |
| Secondary | Percentage of Participants With BPAR - Worst-case Scenario | 3 Months, 12 months | A biopsy-proven acute rejection was defined as a biopsy graded IA, IB, IIA, IIB or III. In the worst-case scenario, failure, i.e. BPAR, was identified in one of the following cases: occurrence of BPAR or study discontinuation due to any reason. |
| Secondary | Percentage of Participants With Delayed Graft Function (DGF) - | 3 Months | DGF was defined as the need for dialysis in the first week after transplant, excluding Renal Replacement Therapy within the first 24 hours after transplantation. |
| Secondary | Duration of DGF | 3 months | The duration of DGF was defined as the elapsed time from first to last day of post-transplant dialysis. |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT | baseline, 3 Months | Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3\*(serum creatinine \[mg/dL\])\^-1.154 \* (age at screening) -0.203 \* (0.742 if female) \* (1.21 if African American). A positive change from baseline indicates improvement. |
| 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 | Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3\*(serum creatinine \[mg/dL\])\^-1.154 \* (age at screening) -0.203 \* (0.742 if female) \* (1.21 if African American). A positive change from baseline indicates improvement. |
| Secondary | Change From Baseline in Serum Creatinine - ITT | baseline, 3 months | Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Serum Creatinine - Modified ITT | baseline, 12 months | Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement. |
| Secondary | Percentage of Participants With Proteinuria | 3 months | Incidence of proteinuria (\>1,000 mg/day in urine collected in 24 hours or \> 1.0 if measured on the urine protein/creatinine concentration ratio in a spot urine sample) was assessed. |
| Secondary | Percentage of Participants With Acute Rejection (AR) | 12 months | AR was defined as an episode of increased serum creatinine \>30% that was clinically diagnosed as an acute rejection but was not biopsy proven. |
| Secondary | Percentage of Participants With a New Onset of Malignancy | 12 months | The percentage of participants with a new onset of malignancy was assessed. |
| Secondary | Percentage of Participants With a New Onset of Diabetes | 12 months | The percentage of participants with a new onset of diabetes was assessed. |
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.
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