# A Pilot Randomized Controlled Trial of De Novo Belatacept-Based Immunosuppression in Lung Transplantation

> **NIH NIH R34** · WASHINGTON UNIVERSITY · 2020 · $237,979

## Abstract

PROJECT SUMMARY/ABSTRACT
 Chronic lung allograft dysfunction (CLAD) has emerged as the primary obstacle to long-term survival
after lung transplantation. Although the pathogenesis of CLAD remains unclear, clinical risk factors including
acute cellular rejection (ACR), lymphocytic bronchiolitis (LB), primary graft dysfunction (PGD), and the
development of donor-specific antibodies (DSA) to mismatched human leukocyte antigens (HLA) have been
consistently identified. Approximately 50% of lung transplant recipients develop DSA within the first year after
transplantation. Clinical studies illustrate that DSA plays a central role in the development of CLAD and is
associated with an increased risk of death. DSA increase the risk of high-grade and persistent ACR and LB.
Furthermore, experimental studies suggest that antibodies to mismatched major histocompatibility complex
(MHC) antigens have a direct pathogenic effect on the allograft resulting in airway lesions similar to human
obliterative bronchiolitis.
 This project will use a pilot randomized controlled trial to assess the feasibility of conducting a large-
scale randomized controlled trial that tests the hypothesis that Belatacept inhibits the development of DSA,
decreases the risk of CLAD, and improves survival after lung transplantation. This pilot study's primary
endpoint is a composite of DSA development, death, or re-transplantation, and key secondary endpoints are
ACR, LB, antibody-mediated rejection (AMR), and CLAD. This project addresses an important problem in lung
transplantation, and has the potential to change clinical practice and improve outcomes for lung transplant
recipients.

## Key facts

- **NIH application ID:** 9948711
- **Project number:** 5R34HL138186-03
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** HOWARD J HUANG
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $237,979
- **Award type:** 5
- **Project period:** 2018-07-10 → 2022-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9948711

## Citation

> US National Institutes of Health, RePORTER application 9948711, A Pilot Randomized Controlled Trial of De Novo Belatacept-Based Immunosuppression in Lung Transplantation (5R34HL138186-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9948711. Licensed CC0.

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