Protocol core needle biopsy and histologic Chronic Allograft Damage Index (CADI) as surrogate end point for long-term graft survival in multicenter studies
| Autor: | Timo Paavonen, Steven Tomlanovich, E L Ramos, Pekka Häyry, Timothy Mathew, Merci Navarro, Eero Taskinen, Leon Hooftman, Serdar Yilmaz |
|---|---|
| Rok vydání: | 2003 |
| Předmět: |
Graft Rejection
Male medicine.medical_specialty Urology Kidney Severity of Illness Index chemistry.chemical_compound Predictive Value of Tests Risk Factors Severity of illness Biopsy medicine Humans Multicenter Studies as Topic Risk factor Observer Variation Creatinine medicine.diagnostic_test business.industry Surrogate endpoint Biopsy Needle Graft Survival General Medicine Kidney Transplantation Surgery Transplantation chemistry Nephrology Predictive value of tests Chronic Disease Disease Progression Female Complication business |
| Zdroj: | Journal of the American Society of Nephrology : JASN. 14(3) |
| ISSN: | 1046-6673 |
| Popis: | This study is an investigation of whether a protocol biopsy may be used as surrogate to late graft survival in multicenter renal transplantation trials. During two mycophenolate mofetil trials, 621 representative protocol biopsies were obtained at baseline, 1 yr, and 3 yr. The samples were coded and evaluated blindly by two pathologists, and Chronic Allograft Damage Index (CADI) score was constructed. At 1 yr, only 20% of patients had elevated (l.5 mg/100 ml) serum creatinine, whereas 60% of the biopsies demonstrated an elevated (2.0) CADI score. The mean CADI score at baseline, 1.3 +/- 1.1, increased to 3.3 +/- 1.8 at 1 yr and to 4.1 +/- 2.2 at 3 yr. The patients at 1 yr were divided into three groups, those with CADI2, between 2 and 3.9, and4.0, the first two groups having normal (1.4 +/- 0.3 and 1.5 +/- 0.6 mg/dl) and the third group pathologic (1.9 +/- 0.8 mg/dl) serum creatinine. At 3 yr, there were no lost grafts in the low CADI group, six lost grafts (4.6%) in the in the elevated CADI group, and 17 lost grafts (16.7%) in the high CADI group (P0.001). One-year histologic CADI score predicts graft survival even when the graft function is still normal. This observation makes it possible to use CADI as a surrogate end point in prevention trials and to identify the patients at risk for intervention trials. |
| Databáze: | OpenAIRE |
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