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

May 26, 2026 updated by: Anhui Provincial Hospital

A Prospective Randomized Controlled Study of Low-Dose Versus Standard-Dose Trimethoprim-Sulfamethoxazole for the Prevention of Pneumocystis Jirovecii Pneumonia After Kidney Transplantation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pneumocystis jirovecii pneumonia (PJP) remains a significant opportunistic infection in kidney transplant recipients and continues to pose a major clinical challenge. Although trimethoprim-sulfamethoxazole (TMP-SMX) is widely used for prophylaxis, its tolerability is often limited by adverse effects, which may compromise adherence during long-term use. Therefore, identifying an optimal dosing strategy that maintains efficacy while improving safety is of considerable clinical importance.

This multicenter, prospective, randomized controlled trial is designed to compare the efficacy and safety of low-dose versus standard-dose TMP-SMX for PJP prophylaxis after kidney transplantation. Adult kidney transplant recipients with stable renal function after transplantation will be enrolled and randomly assigned in a 1:1 ratio to receive either a low-dose or standard-dose TMP-SMX regimen for 12 months following transplantation.

The primary outcome is the incidence of PJP during the 12-month prophylaxis period. Secondary outcomes include treatment-related adverse events, rates of dose modification or discontinuation, and the occurrence and timing of PJP after cessation of prophylaxis, as well as other post-transplant clinical outcomes. All participants will be followed for a total of 24 months, including a 12-month treatment period and an additional follow-up period after discontinuation. The results of this study are expected to provide evidence to inform optimal prophylactic strategies for PJP in kidney transplant recipients, with the aim of improving both efficacy and safety in clinical practice.

Study Type

Interventional

Enrollment (Estimated)

1084

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-Age: Between 18 and 70 years old. Transplant Status: Recipients of a first-time kidney transplant. Renal Function: Serum creatinine levels have stabilized with a creatinine -----clearance (CrCl) > 30 mL/min.

Consent & Compliance: Voluntarily agree to participate in this study, are capable of cooperating with the investigators, and have signed the informed consent form.

Exclusion Criteria:

-HIV Infection: Known HIV positive status. Drug Allergy: History of allergy or hypersensitivity to TMP-SMX (Trimethoprim-Sulfamethoxazole).

Prior PJP: History of Pneumocystis jirovecii pneumonia (PJP) before transplantation.

G6PD Deficiency: Glucose-6-phosphate dehydrogenase deficiency. Multi-organ Transplant: Recipients of multi-organ transplants. Active Infection: Presence of other severe concurrent infections. Immune System Disorders: Concomitant diseases affecting the immune system (e.g., malignancies/tumors, connective tissue diseases, hematological system diseases).

Pregnancy: Pregnant women. Anemia: Megaloblastic anemia. Non-compliance: Inability to adhere to regular follow-up schedules or poor compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Dose Group
Participants receive standard-dose trimethoprim-sulfamethoxazole (TMP-SMX) 80/400 mg once daily for 12 consecutive months for the prevention of Pneumocystis jirovecii pneumonia (PJP) after kidney transplantation.
Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)
80/400 mg orally once daily for 12 consecutive months for the prophylaxis
Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)
40/200 mg orally once daily for 12 consecutive months for the prophylaxis
Experimental: Low Dose Group
Participants receive trimethoprim-sulfamethoxazole (TMP-SMX) 40/200 mg (half tablet) once daily for 12 consecutive months for the prevention of Pneumocystis jirovecii pneumonia (PJP) after kidney transplantation.
Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)
80/400 mg orally once daily for 12 consecutive months for the prophylaxis
Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)
40/200 mg orally once daily for 12 consecutive months for the prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Pneumocystis jiroveciipneumonia (PJP) during the 12-month prophylaxis period after kidney transplantation
Time Frame: 12 months post-kidney transplantation
The frequency of newly diagnosed Pneumocystis jiroveciipneumonia (PJP) cases occurring within 12 months after kidney transplantation in each group. Diagnosis is confirmed by clinical symptoms, radiological evidence, and microbiological detection (e.g., PCR or staining).
12 months post-kidney transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of TMP-SMX related adverse events during prophylaxis
Time Frame: 12 months post-kidney transplantation
Frequency of adverse events (AEs) associated with trimethoprim-sulfamethoxazole (TMP-SMX) during the 12-month prophylaxis period. AEs include but are not limited to rash, gastrointestinal intolerance, hematologic abnormalities (e.g., leukopenia), and hepatorenal dysfunction.
12 months post-kidney transplantation
Incidence of PJP during the 1-year follow-up after prophylaxis
Time Frame: 12 to 24 months post-kidney transplantation
Frequency of PJP cases, with PJP onset defined as the date of obtaining microbiological evidence, during the 12-month period following completion of prophylaxis.
12 to 24 months post-kidney transplantation
Incidence of other post-transplant complications
Time Frame: 12 months post-kidney transplantation

Frequency of other clinically significant complications occurring within 12 months post-transplant, including:

Other infections (excluding PJP): bacterial, viral (e.g., CMV, BK virus), fungal, urinary tract, and gastrointestinal infections.

Acute rejection episodes. New-onset hypertension or diabetes mellitus.
12 months post-kidney transplantation
Clinical prognosis of patients diagnosed with PJP
Time Frame: 24 months post-kidney transplantation

Clinical outcomes among participants who develop PJP, including:

Rate of invasive mechanical ventilation (intubation). Rate of ICU admission. All-cause mortality. Graft survival rate.
24 months post-kidney transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Hospital

Collaborators

The First Affiliated Hospital of Anhui Medical University
The Second Hospital of Anhui Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

May 26, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025KY938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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