Efficacy Evaluation of Modified Zhixiao Tongmai Ning in Preventing Radiation-Induced Kidney Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Modified Zhixiao Tongmai Ning
DrugPatients 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
DrugPatients 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.
Treatment groups
194 Participants
are divided into 2 treatment groupsGroup A: Modified Zhixiao Tongmai Ning + RadiotherapyExperimental treatment 1 intervention
Group B: Standard Radiotherapy AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Radiation-Induced Kidney Injury
Assessment of radiation-induced kidney injury (radiation nephropathy) based on the decline in estimated glomerular filtration rate (eGFR) and serum creatinine levels compared to baseline, or clinical diagnostic criteria (e.g., RTOG/EORTC criteria). Evaluated at baseline, end of radiotherapy, and during follow-up visits.
Time frame
From baseline to 6 months after the completion of radiotherapySecondary outcomes
1
Changes in Serum Creatinine and eGFR
Measurement of serum creatinine levels and estimated glomerular filtration rate (eGFR) changes from baseline compared between the two groups.
Time frame
From baseline to 6 months after completion of radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov