Trial · NCT01729494
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Composite Endpoint of Experiencing Either Death, Graft Loss, or eGFR < 45ml/Min | 12 months | Number of Patients who experienced any of the following including patient Death or Graft Loss or had an estimated GFR (eGFR) (MDRD) \< 45 mL/min |
| Secondary | Number of Patients Experiencing a Graft Loss But Not Including Patients Who Died With Functioning Graft (Death-censored Graft Loss) | 24 months | Number of patients who experienced Graft loss, not including (censored) patients who lost graft due to death |
| Secondary | Number of Patients With Composite Endpoint of Either Experiencing Death, Graft Loss, or eGFR < 45ml/Min at 24 Months | 24 months | Composite Endpoint of number of patients who experienced either patient death, allograft loss, or had an eGFR \< 45 ml/min/1.73m2 |
| Secondary | eGFR (MRDRD) < 45 ml/Min/1.73m2 | 24 months | Patients with reduced Renal function measured by estimated GFR MDRD \< 45 ml/min at 24 months |
| Secondary | Biopsy Proven Acute Rejection | 24 months | Incidence of all biopsy proven acute rejection whether clinically relevant or clinically silent. |
| Secondary | Biopsy Proven Acute Cellular Rejection | 24 months | Biopsy proven acute cellular rejection (BPACR) |
| Secondary | Biopsy Proven Acute Antibody Mediated Rejection | 24 months | Incidence of patients experiencing a Biopsy proven acute antibody mediated rejection (BPAMR) |
| Secondary | Biopsy Proven Mixed Acute Rejection | 24 months | Incidence of patients experiencing a Biopsy proven acute cellular rejection with either DSA positive or C4d staining positive indicating antibody rejection |
| Secondary | Number of Patients Developing Denovo Donor Specific Antibody (DSA) Post-transplant | 24 months | Number of patients (%) with development of denovo DSA after transplant |
| Secondary | Mean eGFR (MDRD) (ml/Min/1.73m2) | 24 months | Mean eGFR (MDRD) (ml/min/1.73m2) measured for all patients reaching 2 year endpoint |
| Secondary | Proteinuria UPC Ratio > 0.8 | 24 months | Number of Patients with a Urine protein/creatinine (UPC) ratio \> 0.8 |
| Secondary | Patient Death | 24 months | Number of Patients who experienced death, all causes |
| Other | Requirement of T-cell Depleting Therapy for Biopsy Proven Acute Rejection (BPAR) | 24 months | Number of patients requiring anti-lymphocyte therapy for the treatment of BPAR rejection |
| Other | New Onset Diabetes After Transplantation (NODAT) | 24 months | Number of patients developing New Onset Diabetes Mellitus after Transplant by one of 5 definitions; only patients without preexisting diabetes were included |
| Other | Time to First BPAR | 24 months | Mean Time to first episode of BPAR (days) |
| Other | # Patients Experiencing a First Biopsy-proven ACR With Severity Banff > or = 2a Grade | 24 months | Number of patients with their First BPACR with a Banff grade \>= Banff 2a using the Banff 2007 classification system for biopsy grading. Banff grade 2a and above is considered severe cellular rejection and includes grades of Banff 2a, Banff 2b, and Banff 3. |
| Other | Delayed Graft Function | 24 months | Number of patients experiencing Delayed graft function (DGF) within first week after transplant. DGF is defined as need for dialysis within the first week after transplant. |
| Other | Leukopenia (WBC < 2000/mm3) | 24 months | Number of patients developing leukopenia defined as WBC \< 2000/mm3 |
| Other | Steroid Therapy | 24 months | Number of patients on treatment with corticosteroids at 2 years |
| Other | Discontinuation of Mycophenolate | 24 months | Number of patients who were discontinued from mycophenolate treatment at 2 years |
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/NCT01729494/registered