RECRUITING Phase 2 ClinicalTrials.gov

Efficacy Evaluation of Modified Zhixiao Tongmai Ning in Preventing Radiation-Induced Kidney Injury

Sponsor: Peking University First Hospital • ClinicalTrials.gov ID: NCT07849088

Registry updated: 2026-09-30

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Description

This prospective randomized controlled study evaluates the clinical efficacy of modified Zhixiao Tongmai Ning in preventing radiation-induced kidney injury in cancer patients. We will assess improvements using routine lab indicators (e.g., glomerular filtration rate, serum creatinine, urine tests), Traditional Chinese Medicine (TCM) syndrome criteria, patient-reported scores, and renal dynamic imaging. The study aims to identify the most suitable patient subgroups and optimal timing for drug use by analyzing baseline factors, radiation parameters, and concurrent treatments, thereby optimizing the formula. Additionally, we will collect blood and urine samples to explore potential mechanisms, focusing on inflammatory factors like TNF-α and IL-6, to support future basic research and clinical application.

Interventions

Modified Zhixiao Tongmai Ning (Drug)
Patients will receive modified Zhixiao Tongmai Ning (a Traditional Chinese Medicine formula for clearing heat and nourishing Yin) orally, twice daily, throughout the course of radiotherapy and the follow-up period. The administration is combined with kidney-sparing radical radiotherapy for renal malignancies. The specific dosage will be adjusted based on individual TCM syndrome differentiation and clinical condition.
Standard Radiotherapy Alone (Drug)
Patients will receive standard care or a matching placebo orally, twice daily, throughout the course of radiotherapy and the follow-up period, combined with the same kidney-sparing radical radiotherapy for renal malignancies.

Eligibility 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.

Conditions

Cancer Patients Receiving Radiotherapy for Kidney Malignancies

Locations

Department of Radiotherapy Oncology, Peking University First Hospital — Beijing, Beijing Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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