Protocol core needle biopsy and histologic Chronic Allograft Damage Index (CADI) as surrogate end point for long-term graft survival in multicenter studies
S Yilmaz, S Tomlanovich, T Mathew… - Journal of the …, 2003 - journals.lww.com
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 (> …
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 (> …