Actively Recruiting
Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery: a Single-center Randomized Controlled Study (KISS Study)
Led by Jinling Hospital, China · Updated on 2025-12-15
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of salt substitutes to protect kidney function after surgery for kidney tumors in this open-label, randomized controlled trial. The study aims to determine if a salt substitute diet can improve estimated glomerular filtration rate (eGFR) compared to a regular salt diet. It also examines the safety, patient compliance, and feasibility of using salt substitutes in the diet of postoperative kidney tumor patients. Participants will be assigned to either a salt substitute group or a regular salt group. They will consume their assigned type of salt daily while adhering to WHO-recommended salt intake levels for one year. The study provides free salt substitutes in phases, with adherence checks at scheduled follow-ups. Telemedicine follow-up is planned at 9 months to support compliance. Non-adherence will lead to education or discontinuation from the study. Participants will undergo assessments at 1, 3, 6, and 12 months after surgery, including 24-hour urine tests at months 1 and 6 to monitor adherence. Researchers will regularly monitor blood electrolytes, eGFR, and other kidney function markers. They will record any adverse events or health changes. The primary outcome is eGFR at 12 months post-surgery, with secondary outcomes including eGFR decline rate, CKD progression, proteinuria progression, adverse events, and quality of life measured over the year-long follow-up.
CONDITIONS
Brief 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 participant and cohabiting family members
- Age 18 years or older at enrollment, any gender
- Diagnosed with kidney tumor and undergone radical or partial nephrectomy
- Preoperative eGFR greater than 60 ml/min/1.73m²
- Serum potassium less than 4.8 mmol/L
- Home-based dietary habits with over 90% meals prepared at home
- Normal contralateral kidney function at screening
- Normal heart, lung, and liver function
You will not qualify if you...
- Current use of potassium-sparing diuretics, potassium supplements, or prior use of salt substitutes by participant or cohabiting family
- Post-discharge eGFR less than 45 ml/min/1.73m² without significant fluctuation
- Comorbid chronic kidney diseases such as diabetic nephropathy or lupus nephritis
- History of urinary tract obstruction before surgery
- Cohabiting family members with CKD (eGFR less than 45 ml/min/1.73m²)
- Planned use of nephrotoxic medications after surgery
- Uncontrolled diabetes with HbA1c 12% or higher
- Uncontrolled high blood pressure (SBP 180 mmHg or higher or DBP 110 mmHg or higher), symptomatic low blood pressure, or obvious low blood volume
- Preoperative proteinuria of 1+ or higher on dipstick
- Severe heart disease (NYHA Class III-IV), gastrointestinal obstruction, or history of high potassium
- Body mass index less than 18.5 or greater than 30 kg/m²
- Participation in another clinical trial within 30 days before randomization or concurrently
- Communication barriers or expected non-adherence
- Structural or functional urinary tract abnormalities or use of indwelling catheters
- Prior radiotherapy, ablation, or surgery on the opposite kidney
- Life expectancy less than 6 months due to conditions like metastatic renal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants consume salt substitutes daily while strictly adhering to WHO-recommended salt intake levels for 1 year after kidney tumor surgery. Free salt substitute supplies are provided at discharge and during follow-up visits based on adherence assessments.
1 visit at hospital discharge, followed by visits at 1, 3, 6, 9 (telemedicine), and 12 months post-operation
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
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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