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

NCT07619027 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025KY938
• Study Type: interventional
• Target: 1,084
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pneumocystis Jirovecii Pneumonia; Kidney Transplantation

Keywords

PJP prophylaxis; Kidney transplant recipients; Trimethoprim-Sulfamethoxazole; Low-dose

Outcome Measures

Primary Outcomes (1)

• Incidence of Pneumocystis jiroveciipneumonia (PJP) during the 12-month prophylaxis period after 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 Outcomes (4)

• Incidence of TMP-SMX related adverse events during prophylaxis

  12 months post-kidney transplantation

• Incidence of PJP during the 1-year follow-up after prophylaxis

  12 to 24 months post-kidney transplantation

• Incidence of other post-transplant complications

  12 months post-kidney transplantation

• Clinical prognosis of patients diagnosed with PJP

  24 months post-kidney transplantation

Study Arms (2)

Standard Dose Group

ACTIVE COMPARATOR

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)

Low Dose Group

EXPERIMENTAL

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)

Interventions

Trimethoprim-Sulfamethoxazole (TMP-SMX) DRUG

80/400 mg orally once daily for 12 consecutive months for the prophylaxis

Standard Dose Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• The Second Hospital of Anhui Medical University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator

MeSH Terms

Conditions

Pneumonia, Pneumocystis

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

Xuqin jiang

CONTACT

+86-13675605989; xqjiang@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share