MedDataX Logo

Sulfamethoxazole Prophylaxis Duration After Renal Transplantation

NCT ID: NCT07231770

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-28

Study Completion Date

2027-08-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Renal transplantation is the most ideal and effective treatment for end-stage renal disease. Pneumocystis jirovecii pneumonia (PJP) is one of the most common pulmonary infections after renal transplantation, with high morbidity and mortality that seriously affects patients' prognosis and survival. PJP can be prevented with drugs, and trimethoprim-sulfamethoxazole (TMP-SMX) is the first-choice prophylactic agent. However, there is no clear definition of the prophylactic course of TMP-SMX in domestic and international guidelines. Most of the prophylactic durations for PJP are based on the clinical experience of physicians, ranging from 6 to 12 months across different transplant centers. Multiple studies have shown that some patients still develop PJP more than one year after renal transplantation. Previous research by our team found that PJP has a peak incidence around 9 months after renal transplantation, with a second peak occurring between 10 and 15 months. This study aims to adopt a single-center, randomized, parallel-controlled trial design, planning to enroll 450 patients after renal transplantation. It will investigate the impact of different prophylactic courses of TMP-SMX on the incidence of PJP, and explore whether long-term prophylaxis is more reasonable and effective than short-term prophylaxis. Meanwhile, during follow-up, the peak serum concentration of SMZ in patients will be measured to analyze the relationship between SMZ serum concentration and the occurrence of PJP as well as adverse reactions. A clinical prediction model will be constructed to reveal the effective concentration range of TMP-SMX for prophylactic use. This will further optimize the prophylactic regimen, provide practical guidance for clinical practice, reduce the morbidity and mortality of PJP, and improve prognosis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fever Chest Tightness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A group

6-month SMZ prophylaxis

Group Type OTHER

Time-driven dosing

Intervention Type OTHER

The total sample size required for the study is 450 cases. Patients will then be screened for enrollment according to the inclusion and exclusion criteria, and randomly assigned to Groups A, B, and C in a 1:1:1 ratio, with 150 patients in each group. Group A will receive TMP-SMX prophylaxis against PJP for 6 months, while Groups B and C will each receive TMP-SMX prophylaxis against PJP for 12 months.

B group

12-month SMZ prophylaxis

Group Type OTHER

Time-driven dosing

Intervention Type OTHER

The total sample size required for the study is 450 cases. Patients will then be screened for enrollment according to the inclusion and exclusion criteria, and randomly assigned to Groups A, B, and C in a 1:1:1 ratio, with 150 patients in each group. Group A will receive TMP-SMX prophylaxis against PJP for 6 months, while Groups B and C will each receive TMP-SMX prophylaxis against PJP for 12 months.

C group

18-month SMZ prophylaxis

Group Type OTHER

Time-driven dosing

Intervention Type OTHER

The total sample size required for the study is 450 cases. Patients will then be screened for enrollment according to the inclusion and exclusion criteria, and randomly assigned to Groups A, B, and C in a 1:1:1 ratio, with 150 patients in each group. Group A will receive TMP-SMX prophylaxis against PJP for 6 months, while Groups B and C will each receive TMP-SMX prophylaxis against PJP for 12 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Time-driven dosing

The total sample size required for the study is 450 cases. Patients will then be screened for enrollment according to the inclusion and exclusion criteria, and randomly assigned to Groups A, B, and C in a 1:1:1 ratio, with 150 patients in each group. Group A will receive TMP-SMX prophylaxis against PJP for 6 months, while Groups B and C will each receive TMP-SMX prophylaxis against PJP for 12 months.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects must meet all the following conditions to be enrolled: (1) Age: 18-70 years old; (2) Post-renal transplantation; (3) Voluntarily participate in this clinical study, be able to cooperate with researchers to conduct the study, and sign the informed consent form.

Exclusion Criteria

* Criteria: Subjects with any of the following conditions shall be excluded from the trial: (1) HIV-positive; (2) History of TMP-SMX allergy; (3) Glucose-6-phosphate dehydrogenase (G6PD) deficiency; (4) Megaloblastic anemia; (5) Multiorgan transplantation; (6) Complicated with tumor; (7) Complicated with connective tissue disease; (8) Pregnant patients.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

No. 17, Lujiang Road, Luyang District, Hefei City, Anhui Province, China

Hefei, Anhui, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xuqin Jiang

Role: CONTACT

[email protected]
13675605989

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xuqin Jiang

Role: primary

[email protected]
13675605989

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-ky041

Identifier Type: OTHER

Identifier Source: secondary_id

USTC-PJP-Pro

Identifier Type: -

Identifier Source: org_study_id