Actively Recruiting
Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery
Led by Jinling Hospital, China · Updated on 2025-12-15
200
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is an open-label, randomized controlled study designed to evaluate the efficacyand safety of salt substitutes in protecting renal function after kidney tumor surgery, aiming toprovide dietary renal protection strategies for postoperative kidney tumor patients. lt will alsoassess the feasibility of salt substitute intervention. The primary research questions are: 1. Does a salt substitute diet significantly improve estimated glomerular filtration rate (eGFR) compared to a regular salt diet in postoperative kidney tumor patients? 2. What is the safety profile of salt substitute intervention in postoperative kidney tumor patients? 3. What is the compliance rate among postoperative kidney tumor patients using saltsubstitutes? 4. ls the salt substitute intervention feasible? Researchers will compare the intervention group (salt substitute diet) with the control group (regular salt diet) to determine whether salt substitutes effectively improve postoperative eGFR in kidney tumor patients. Participants will be required to: 1. Consume salt substitutes or regular salt daily while strictly adhering to WHO-recommendedsalt intake levels for 1 year. 2. Undergo scheduled baseline assessments at 1, 3, 6, and 12 months post-surgery, with 24-hoururine tests at months 1 and 6 to evaluate compliance. 3. Receive regular monitoring of blood electrolytes, eGFR, and other renal function indicators. 4. Document any adverse events or health status changes during the study period.
CONDITIONS
Official Title
Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent from the participant and cohabiting family members, with commitment to study procedures and follow-up
- Age 18 years or older at enrollment
- Diagnosed with kidney tumor and underwent radical or partial nephrectomy
- Preoperative estimated glomerular filtration rate (eGFR) greater than 60 ml/min/1.73m²
- Serum potassium level below 4.8 mmol/L
- Predominantly home-based dietary habits with more than 90% of meals prepared at home
- Normal function of the opposite kidney at screening
- Normal heart, lung, and liver function
You will not qualify if you...
- Currently using potassium-sparing diuretics, potassium supplements, or prior use of salt substitutes by participant or cohabiting family members
- Post-discharge eGFR less than 45 ml/min/1.73m² without significant fluctuation
- Presence of chronic kidney diseases such as diabetic nephropathy or lupus nephritis
- History of urinary tract obstruction before surgery
- Cohabiting family members with chronic kidney disease (eGFR less than 45 ml/min/1.73m²)
- Planned use of nephrotoxic medications after surgery including anti-neoplastic agents or immunotherapy
- Uncontrolled diabetes with HbA1c 12% or higher
- Uncontrolled high blood pressure (seated systolic BP 180 mmHg or higher, or diastolic BP 110 mmHg or higher), symptomatic low blood pressure (systolic BP below 90 mmHg), or clear signs of low blood volume
- Preoperative proteinuria of 1+ or more on dipstick test
- Severe heart disease (NYHA Class III-IV), gastrointestinal blockage, or history of high potassium levels
- Body mass index (BMI) below 18.5 kg/m² or above 30 kg/m²
- Participation in another clinical trial within 30 days before randomization or during this study
- Communication difficulties or expected inability to follow study procedures
- Structural or functional urinary tract abnormalities or use of indwelling catheters
- Previous radiotherapy, ablation, or surgery on the opposite kidney
- Life expectancy less than 6 months due to conditions like metastatic kidney cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
Q
Qu Le M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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