Kidney Graft Dysfunction Clinical Trial
— KALIMBOOfficial title:
Impact of Acute and Chronic Individual Histological Lesions and Composite Scores in Implantation Biopsies on Short-term and Long-term Kidney Allograft Outcomes
The morphology of transplanted kidney is considered to be important for graft outcomes in early and late posttransplant period. Individual histological lesions at the time of kidney transplantation, such as sclerosis of glomeruli, vascular narrowing and interstitial fibrosis, and composite histological lesions, which integrate histopathological findings in different compartments, showed association with suboptimal graft outcomes. However there are no consistent association between individual or composite lesions and transplant outcomes. Some possible explanations for such inconsistent results are non-uniformity in grading histological lesions or in defining graft outcomes. Furthermore, studies vary in terms of patient selection, and some results are not corrected for covariates. It is also unclear, whether acute biopsy features associated with the donor kidney can provide prognostic information, in addition to the chronic lesions? This single-center study aimed to evaluate which acute and chronic histological lesions and composite histological scores in donor kidney intraoperative biopsies alone or in combination with clinical variables are best associated with short- and long-term kidney graft outcomes, such as impairment of early kidney allograft function, immunological acute kidney allograft rejection, pyelonephritis, allograft function at 1, 3, 6, 12 months, 2, 3, 4 and 5 years, and graft survival at 1 and 5 years.
Status | Completed |
Enrollment | 130 |
Est. completion date | December 31, 2015 |
Est. primary completion date | December 31, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - adult kidney transplant recipients who underwent transplantation at Zaporizhzhia Transplant Center; - cadaveric or living single kidney only transplant; - informed written consent; - adequate intraoperative biopsy (in total = 7 glomeruli and = 1 arteries in preimplant and postreperfusion biopsies); - complete follow-up data up to 5 years. Exclusion Criteria: - not consent with research; - non-complete follow-up data up to 5 years. |
Country | Name | City | State |
---|---|---|---|
Ukraine | Laboratory Diagnostics and General Pathology Department, State Institution "Zaporizhzhia Medical Academy of Post-Graduate Education Ministry of Health of Ukraine" | Zaporizhzhia |
Lead Sponsor | Collaborator |
---|---|
Andriy Trailin |
Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Five-year death-censored kidney allograft survival | The time of graft failure was defined as return to dialysis therapy | Five years | |
Secondary | Delayed graft function | Delayed graft function was defined as the need for dialysis in the first postoperative week without evidence of acute rejection or pyelonephritis | The day 8 | |
Secondary | Slow graft function | Slow graft function was defined as serum creatinine on day seven =300 µmol/L without evidence of acute rejection or pyelonephritis. | The day 8 | |
Secondary | Acute rejection | Acute rejection was defined by characteristic clinical symptoms and ultrasound findings and by the need for treatment, with or without biopsy confirmation. | During five years | |
Secondary | Pyelonephritis | Pyelonephritis was defined by characteristic symptoms, a urine sediment analysis, and a urinary culture test. | During five years | |
Secondary | Allograft function at 1, 3, 6, 12 months, 2, 3, 4 and 5 years | Allograft function at 1, 3, 6, 12 months, 2, 3, 4 and 5 years was assessed with glomerular filtration rate (CKD-EP equation). | During five years | |
Secondary | One-year death-censored kidney allograft survival | The time of graft failure was defined as return to dialysis therapy | One year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT01492894 -
Kidney Allograft Dysfunction Without Reversible Causes
|
Phase 4 |