Clinical Research Directory

Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)

In this pragmatic clinical trial, which will dovetail with Veterans' routine outpatient dialysis clinic visits in six VA medical centers, the investigators will study 252 Veterans with kidney disease who need to start dialysis treatment. If a Veteran is eligible for the study by making enough residual urine, he/she will have a 50% chance to be offered the usual three-times-per-week dialysis vs. twice-per-week dialysis that is gradually increased to three-times per- week over one year. The investigators will compare health-related quality of life, how long residual kidney function lasts, and other measures including safety in these two groups. By conducting this study, the investigators hope to understand 1) whether starting dialysis with less frequency is safe, effective, and can help Veterans and their care-partners to better cope with dialysis, and 2) if incremental dialysis can result in major cost benefits to the VA health care system, thus allowing more patients to stay in VA dialysis clinics vs. being transferred to outside clinics.

Development and Validation of HistoMX, a Gene-Expression Platform for Molecular Interpretation of Kidney Allograft Biopsies

This retrospective multicentre observational study developed and validated HistoMX, an automated gene-expression-based platform for multidimensional molecular interpretation of kidney allograft biopsies. The study included 2,410 archived post-transplant kidney allograft biopsy samples from adult kidney transplant recipients. Formalin-fixed paraffin-embedded biopsy tissue was profiled using the Banff Human Organ Transplant panel on the NanoString nCounter platform. HistoMX integrates locked preprocessing, quality control, single-sample normalization, diagnostic classification, Banff lesion-level modelling, molecular lesion-severity scores, composite injury indices, immune-cell estimation, pathway-enrichment analysis, and automated clinician-facing reporting. The platform was evaluated against reference histology based on the Banff classification. HistoMX was designed to complement, not replace, conventional histopathology by providing standardized molecular evidence across diagnostic, lesion-level, continuous injury, and biological dimensions of kidney allograft injury.

PD Catheter Survival: Modified Percutaneous vs Moncrief-Popovich

Peritoneal dialysis (PD) catheter placement technique may affect catheter survival, functionality and infection risk. The Moncrief-Popovich (subcutaneous burying or embedding) technique was developed to reduce exit-site/tunnel infections during the interval between insertion and first use. Objective: Compare PD catheter survival, functionality and complication rates between conventional modified percutaneous placement and Moncrief-Popovich in adults initiating planned PD. Brief methods: Prospective, randomized, parallel-arm study enrolling adult CKD patients scheduled for planned PD initiation and catheter placement at Hospital Civil de Guadalajara between Jan 2024 and Dec 2025. Patients randomized 1:1 to conventional modified percutaneous placement group or Moncrief-Popovich buried catheter group. Primary outcome is catheter survival/functionality during follow-up. Secondary outcomes include infectious and mechanical complications, peritonitis incidence, and need to change dialysis modality.