Clinical Trial

Low- vs Standard-Dose TMP-SMX for Prevention of Pneumocystis Pneumonia After Kidney Transplantation

Study acronym: TMP-SMX PJP
Not Yet Recruiting Phase 4
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Summary
This study is a prospective randomized controlled trial designed to evaluate the efficacy and safety of low-dose versus standard-dose trimethoprim-sulfamethoxazole (TMP-SMX) for the prevention of Pneumocystis jirovecii pneumonia (PJP) in kidney transplant recipients. Participants will be randomly assigned to receive either low-dose or standard-dose TMP-SMX for 12 months after kidney transplantation. The primary outcome is the incidence of PJP during the prophylaxis period. Secondary outcomes include adverse events related to TMP-SMX, dose reduction or discontinuation rates, incidence and timing of PJP after discontinuation, and other post-transplant complications. Participants will be followed for a total of 24 months, including a 12-month prophylaxis period and an additional 12-month follow-up period after discontinuation. This study aims to provide evidence for optimizing prophylactic strategies against PJP in kidney transplant recipients.
Trial Details
NCT Number NCT07619027
Lead Sponsor Anhui Provincial Hospital
Collaborators: The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Anhui Medical University
Conditions Pneumocystis Jirovecii Pneumonia, Kidney Transplantation
Enrollment 1,084 participants
Start Date 2026-06
Primary Completion 2028-06 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-01