# Core A: Clinical

> **NIH NIH U19** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2020 · $444,900

## Abstract

CORE A: Clinical
SUMMARY/ABSTRACT
This Core project will perform the central task of patient screening and enrollment, training of personnel, IRB
application preparation, monitoring of clinical study components, sample collection, and collection of
demographic data in concert with the Data Management and Analysis Core C through the following Aims:
Aim 1: Study initiation, screening and subject enrollment. This goal will be realized through the experience
and clinical trials expertise of the clinical leads at each site and will include reaching targets in patient
enrollment and following subjects as they progress through the study, ensuring study visits and CMV PCR
testing dates are not missed, and ensuring that objectives of Good Clinical Practice and regulatory compliance
are met. Aim 2: Specimen collection. Designated study samples including blood, urine and biopsy samples
will be collected according to the established study design and standard clinical practices. The Data
Management and Analysis Core C will support this Aim by providing software support for automatic patient
tracking. Aim 3: Clinical Outcome Collection. Clinical data will be gathered from direct patient contact and
review of the electronic medical record, utilizing the REDCap online data collection tool in collaboration with the
Data Management And Analysis Core C. Data collected will include CMV PCR testing results, CMV disease,
rejection and treatment for rejection, other episodes of infection and quantitative measurements of allograft
function. Aim 4: Safety and monitoring. A Data and Safety Monitoring Board will be convened to capture and
report any adverse events associated with the 24 month kidney biopsy at UCSF, which will be performed for
study purposes. Audits will be performed to ensure that study procedures have been followed and key
research samples, tests and clinical data are collected. Progress of the patient enrollment, unanticipated
problems, protocol deviations and adverse events will be summarized and reported. Accomplishing of the Aims
in this core will provide clinical specimens and clinical data that are essential to the successful execution of
Projects 1-3. The unique transplant volume, diversity, and track record of clinical excellence and clinical trial
leadership at UCLA and UCSF, working in concert with other key Cores, will ensure the success of the
proposed research.

## Key facts

- **NIH application ID:** 10000875
- **Project number:** 5U19AI128913-04
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** Suphamai Bunnapradist
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $444,900
- **Award type:** 5
- **Project period:** 2017-08-01 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10000875

## Citation

> US National Institutes of Health, RePORTER application 10000875, Core A: Clinical (5U19AI128913-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10000875. Licensed CC0.

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