See if Modified Zhixiao Tongmai Ning can keep kidneys healthier during radiotherapy for kidney cancer
Official title: Efficacy Evaluation of Modified Zhixiao Tongmai Ning in Preventing Radiation-Induced Kidney Injury in Cancer Patients
Run by Peking University First Hospital · NCT07849088 · Data updated 2026-11-12
This randomized phase 2 trial tests whether Modified Zhixiao Tongmai Ning helps prevent radiation-related kidney injury in patients with kidney cancers who are receiving radiotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 194 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 11, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | June 1, 2029 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07849088 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with renal malignancies scheduled for kidney-sparing radiotherapy, with baseline eGFR ≥ 60 mL/min/1.73 m² and no severe renal or systemic comorbidities that would interfere with participation.
✕Probably not a fit
Patients with severely reduced renal function, bilateral kidney involvement, or conditions making radiotherapy unsafe or noncompliant may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized phase 2 study evaluates the efficacy of modified Zhixiao Tongmai Ning in preventing kidney injury caused by radiotherapy in cancer patients with renal malignancies. Outcomes include kidney function tests (GFR, creatinine, urinalysis), TCM syndrome criteria, patient-reported measures, and advanced renal imaging to capture multi-dimensional effects. Subgroup analyses based on baseline factors, radiotherapy parameters, and concurrent therapies aim to identify which patients may benefit most and when to initiate the drug. Blood and urine samples will be collected to explore inflammatory mechanisms (TNF-α, IL-6) to support future mechanistic research.
Why it matters
Potential benefit: If successful, patients may experience better preservation of kidney function during radiotherapy and a clearer understanding of who benefits most.
How similar studies have gone: Prior studies in similar TKD compounds have shown potential kidney-protective signals; this trial explores a modified formulation with structured subgroup analyses.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or clinically confirmed renal malignancy scheduled to receive kidney-sparing radical radiotherapy. * Baseline estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m² and serum creatinine within normal limits. * Expected survival of at least 6 months and able to comply with the study protocol and follow-up visits. * Provision of written informed consent prior to any study-related procedures. Exclusion Criteria: * Pre-existing severe renal impairment (e.g., estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73 m²) or history of renal failure. * Known allergy or hypersensitivity to any components of Zhixiao Tongmai Ning or other Traditional Chinese Medicine herbs. * Previous treatment with nephrotoxic agents within 4 weeks prior to enrollment, or bilateral renal involvement making kidney-sparing radiotherapy unfeasible. * Presence of severe uncontrolled systemic diseases (e.g., severe cardiovascular disease, active infection) or expected survival of less than 6 moPregnant or breastfeeding women, or patients with poor compliance who are unable to complete the required follow-up visits.nths.
Where it's running
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Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Xiao ying Li, MD
- Email: 13716109164@139.com
- Phone: +86-13716109164
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.