Pneumocystis Jirovecii PneumoniaPhase 4TMP-SMX PJPNCT07619027
Low- vs Standard-Dose TMP-SMX for Prevention of Pneumocystis Pneumonia After Kidney Transplantation
A Phase 4 study testing Trimethoprim-Sulfamethoxazole (TMP-SMX) in people with Pneumocystis Jirovecii Pneumonia and Kidney Transplantation, run by Anhui Provincial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pneumocystis Jirovecii Pneumonia, Kidney Transplantation
- What is being tested?
- Trimethoprim-Sulfamethoxazole (TMP-SMX)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,084 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- -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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Trimethoprim-Sulfamethoxazole (TMP-SMX)
- Keywords
- PJP prophylaxis, Kidney transplant recipients, Trimethoprim-Sulfamethoxazole, Low-dose
- Medical subject headings
- Pneumonia, Pneumocystis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim-Sulfamethoxazole (TMP-SMX)Drug
80/400 mg orally once daily for 12 consecutive months for the prophylaxis
Trimethoprim-Sulfamethoxazole (TMP-SMX)Drug
40/200 mg orally once daily for 12 consecutive months for the prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months post-kidney transplantation
Secondary outcomes (4)
Incidence of TMP-SMX related adverse events during prophylaxis
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.
Measured: 12 months post-kidney transplantation
Incidence of PJP during the 1-year follow-up after prophylaxis
Frequency of PJP cases, with PJP onset defined as the date of obtaining microbiological evidence, during the 12-month period following completion of prophylaxis.
Measured: 12 to 24 months post-kidney transplantation
Incidence of other post-transplant complications
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.
Measured: 12 months post-kidney transplantation
Clinical prognosis of patients diagnosed with PJP
Clinical outcomes among participants who develop PJP, including:
Rate of invasive mechanical ventilation (intubation). Rate of ICU admission. All-cause mortality. Graft survival rate.
Measured: 24 months post-kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumocystis Jirovecii PneumoniaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,084 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Anhui Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619027
- Sponsor's protocol ID
- 2025KY938
- Acronym
- TMP-SMX PJP
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Low-Dose Versus Standard-Dose Trimethoprim-Sulfamethoxazole for the Prevention of Pneumocystis Jirovecii Pneumonia After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT07619027
- Acronym / sponsor ID
- TMP-SMX PJP / 2025KY938
- Keywords
- PJP prophylaxis, Kidney transplant recipients, Trimethoprim-Sulfamethoxazole, Low-dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,084 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, The Second Hospital of Anhui Medical University
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dose Group | Active comparator | Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)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. |
| Low Dose Group | Experimental | Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -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.
Key exclusion criteria (4 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimethoprim-Sulfamethoxazole (TMP-SMX)80/400 mg orally once daily for 12 consecutive months for the prophylaxis | Drug | Standard Dose Group |
| Trimethoprim-Sulfamethoxazole (TMP-SMX)40/200 mg orally once daily for 12 consecutive months for the prophylaxis | Drug | Low Dose Group |
Primary outcome
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).
4 secondary outcomes
Incidence of TMP-SMX related adverse events during prophylaxis
Time frame: 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
Incidence of other post-transplant complications
Time frame: 12 months post-kidney transplantation
Clinical prognosis of patients diagnosed with PJP
Time frame: 24 months post-kidney transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Pneumocystis Jirovecii Pneumonia
Not yet recruitingPhase 3
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
Pneumocystis Jirovecii Pneumonia
RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
Not yet recruitingObservational study
TMP-SMX for Non-HIV PCP: A Prospective Multicenter Study
Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
RecruitingObservational study
Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
Pneumonia, Fungal Pneumonia
Not yet recruiting
Study on the Impact of Decolonization Treatment of Pneumocystis Jirovecii on the Frequency of Acute Exacerbation in COPD
Chronic Obstructive Pulmonary Disease (COPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trimethoprim-Sulfamethoxazole (TMP-SMX) in people with Pneumocystis Jirovecii Pneumonia and Kidney Transplantation, run by Anhui Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuqin jiang (+86-13675605989, xqjiang@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pneumocystis jiroveciipneumonia (PJP) during the 12-month prophylaxis period after kidney transplantation (time frame: 12 months post-kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.