Kidney TumorsNCT07062952
Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery
A study testing Salt substitute in people with Kidney Tumors and CKD, run by Jinling Hospital, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Tumors, CKD, Salt Substitute
- What is being tested?
- Salt substitute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Voluntary participation with signed informed consent from both the primary participant and all cohabiting family members, with commitment to study procedures and follow-up;
- Age ≥18 years at enrollment (when signing informed consent), any gender;
- Diagnosed kidney tumor patients who underwent radical nephrectomy or partial nephrectomy (no restrictions on surgical approach);
- Preoperative eGFR >60 ml/min/1.73m² (calculated by CKD-EPI equation);
- Serum potassium <4.8 mmol/L;
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- Predominantly home-based dietary habits (>90% meals prepared at home, assessed via self-report);
- Normal contralateral renal function at screening;
- Normal cardiopulmonary and hepatic function:
Who cannot join
- Participants will be excluded if they meet any of the following:
- Participant or cohabiting family members currently using potassium-sparing diuretics or potassium supplements, or prior use of salt substitutes;
- Post-discharge eGFR <45 ml/min/1.73m² without significant fluctuation;
- Comorbid chronic kidney diseases (e.g., diabetic nephropathy, lupus nephritis);
- Preoperative history of urinary tract obstruction;
- Cohabiting family member(s) with CKD (eGFR <45 ml/min/1.73m²);
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- Planned postoperative nephrotoxic medications (e.g., anti-neoplastic agents, immunotherapy);
- Uncontrolled diabetes (HbA1c ≥12%);
- Uncontrolled hypertension (seated SBP ≥180 mmHg or DBP ≥110 mmHg), symptomatic hypotension (SBP <90 mmHg), or clinically evident hypovolemia;
- Preoperative proteinuria (≥1+ on dipstick);
- Severe cardiovascular disease (NYHA Class III-IV), gastrointestinal obstruction, or hyperkalemia history;
- BMI <18.5 kg/m² or >30 kg/m²;
- Participation in another clinical trial ≤30 days before randomization or concurrently;
- Communication barriers or anticipated non-adherence;
- Structural/functional urological abnormalities (e.g., duplicated kidneys, polycystic kidneys, renal artery stenosis, stones, BPH) or indwelling catheters;
- Prior radiotherapy/ablation/surgery on the contralateral kidney;
- Life expectancy <6 months (e.g., metastatic renal carcinoma).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing
Nanjing, Jiangsu, 210000
Qu Le M.D, +86 15720625951, septsoul@hotmail.com
About this study
Official title: Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery: a Single-center Randomized Controlled Study(KISS Study)
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:
- Does a salt substitute diet significantly improve estimated glomerular filtration rate (eGFR) compared to a regular salt diet in postoperative kidney tumor patients?
- What is the safety profile of salt substitute intervention in postoperative kidney tumor patients?
- What is the compliance rate among postoperative kidney tumor patients using saltsubstitutes?
- ls the salt substitute intervention feasible?
Read more
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:
- Consume salt substitutes or regular salt daily while strictly adhering to WHO-recommendedsalt intake levels for 1 year.
- 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.
- Receive regular monitoring of blood electrolytes, eGFR, and other renal function indicators.
- Document any adverse events or health status changes during the study period.
Read the detailed description
Patients after kidney tumor surgery (radical nephrectomy or partial nephrectomy) experience acute loss of functional nephrons, causing compensatory hyperfunction in remaining nephrons under overload conditions. This manifests as elevated glomerular filtration rate (hyperfiltration), increased plasma flow (hyperperfusion), and heightened capillary transmembrane pressure (hypertension), collectively termed the "three-high glomerular state," significantly increasing risks of Acute Kidney Injury(AKI) and long-term Chronic Kidney Disease(CKD). Chinese populations consume salt far exceeding WHO recommendations, with proven associations to hypertension, stroke, cardiovascular disease, kidney disease, and gastric cancer. High salt intake elevates CKD risk through two pathways: chronic high salt consumption induces hypertension (a key CKD risk factor), and activates renal renin-angiotensin-aldosterone system (RAAS), promoting inflammation, fibrosis, and oxidative stress-induced kidney damage-exacerbating the postoperative "three-high state" and further increasing CKD risk. Additionally, Asian populations frequently carry salt-sensitive genetic variants, where both salt sensitivity and high intake cause mineralocorticoid receptor overactivation, independently amplifying CKD susceptibility. Salt substitutes (potassium-enriched low-sodium salt, primarily NaCl and KCl) reduce sodium content versus regular salt, potentially improving renal hemodynamics by lowering sodium load and supplementing potassium to delay renal function decline. Recent multicenter RCTs and meta-analyses confirm cardiovascular benefits: the SSaSS trial demonstrated 13% reduced cardiovascular event risk with potassium-enriched salt (25% KCl), preventing ~460,000 cardiovascular deaths annually via blood pressure control and ~743,000 non-fatal cardiovascular events (including ~120,000 CKD cases) without significant hyperkalemia-related adverse events. The DECIDESalt trial showed significant blood pressure reductions (SBP: -7.1 mmHg; DBP: -1.9 mmHg) and lower cardiovascular risk with salt substitutes versus regular salt, with post hoc analysis indicating reduced hypertension incidence in normotensive individuals without inducing hypotension. Meta-analyses highlight amplified benefits in high-risk populations and Asian diets via sodium-potassium homeostasis and vascular improvement, with clinically insignificant mild potassium elevation confirming efficacy and safety. Despite these cardiovascular benefits, salt substitutes' renal safety and efficacy in post-nephrectomy patients remain unreported. Thus, the investigators propose this open-label randomized controlled trial to evaluate salt substitutes for postoperative renal protection in kidney tumor patients, establishing evidence-based dietary strategies for renal function preservation.
Therefore, the investigators plan to provide study participants with free salt substitute and standardized salt containers (5g) for one year. Participants will receive a one-month supply of free salt substitute upon hospital discharge. Adherence will be assessed at the one-month follow-up visit via 24-hour urine collection. Based on adherence confirmation, the next two-month supply of free salt substitute will be dispensed, continuing until the three-month follow-up.
This process will be repeated for subsequent phases: Adherence will be evaluated at discharge and each follow-up visit before dispensing the next phase's supply of free salt substitute.To enhance adherence during the extended interval between the 6-month and 12-month postoperative follow-ups: A telemedicine follow-up will be conducted at 9 months post-operation.Adherence will be assessed using a self-administered questionnaire, and the salt substitute will be remotely dispensed upon confirmation.
Non-adherence protocol:
First occurrence: Participants will receive intensive education reinforcing the importance of salt substitute use to improve adherence.
Recurrence: Participants will be discontinued from the study.
- Conditions
- Kidney Tumors, CKD, Salt Substitute, Nephrectomy, eGFR
- Being tested
- Salt substitute
- Keywords
- kidney tumor, CKD, Salt substitute, nephrectomy, eGFR, kidney protection, kidney function, open-label, randomized controlled trial, Renal function compensation, CKD with clinical significance
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt substituteDietary supplement
Patient consume salt substitutes daily while strictly adhering to WHO-recommendedsalt intake levels for 1 year.Salt substitutes (potassium-enriched low-sodium salt, primarily NaCl and KCl) reduce sodium content versus regular salt
| Study group | Role | What they receive |
|---|---|---|
| Salt substitute | Experimental | Participants will consume salt substitutes Receives: Dietary Supplement: Salt substitute |
| Common salt | No intervention | Participants will consume Common salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated glomerular filtration rate (eGFR)
Estimated glomerular filtration rate (eGFR) in kidney tumor patients at 12 months after surgery
Measured: Postoperative 12 months
Secondary outcomes (7)
Annual eGFR decline rate
Annual decline rate of eGFR at 12 months postoperatively compared to the "new baseline" post-surgery
Measured: Postoperative 12 months
eGFR decline
Proportion of patients with rapid eGFR decline (>3 ml/min/1.73m²/year) in each group
Measured: Postoperative 12 months
Reduction from baseline
Decline in eGFR at 12 months postoperatively from the new postoperative baseline (ml/min/1.73m²)
Measured: Postoperative 12 months
Incidence of adverse events
Incidence rate of hyperkalemia (serum potassium ≥5.5 mmol/L) and other adverse events
Measured: Postoperative 12 months
Incidence of CKD progression
The 1-year incidence of CKD progression, which was defined as a worse CKD stage compared to baseline.
Measured: Postoperative 12 months
Progression of proteinuria
Progression of proteinuria (defined as ≥30% increase in urine albumin-to-creatinine ratio from baseline)
Measured: Postoperative 12 months
Quality of life questionnaire score
Kidney Disease Quality of Life 36-Item Short Form Survey;The scoring ranges from 0 to 100, with higher scores indicating better quality of life in patients.
Measured: Postoperative 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start24 Apr 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Qu, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062952
- Sponsor's protocol ID
- 2025DZKY-068-01
- Status last verified
- Dec 2025
- First submitted
- 1 Jul 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery: a Single-center Randomized Controlled Study(KISS Study)
- ClinicalTrials.gov ID
- NCT07062952
- Acronym / sponsor ID
- 2025DZKY-068-01
- Conditions
- Kidney Tumors, CKD, Salt Substitute, Nephrectomy, eGFR
- Keywords
- kidney tumor, CKD, Salt substitute, nephrectomy, eGFR, kidney protection, kidney function, open-label
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does a salt substitute diet significantly improve estimated glomerular filtration rate (eGFR) compared to a regular salt diet in postoperative kidney tumor patients?
- What is the safety profile of salt substitute intervention in postoperative kidney tumor patients?
- What is the compliance rate among postoperative kidney tumor patients using saltsubstitutes?
- 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:
- Consume salt substitutes or regular salt daily while strictly adhering to WHO-recommendedsalt intake levels for 1 year.
- 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.
- Receive regular monitoring of blood electrolytes, eGFR, and other renal function indicators.
- Document any adverse events or health status changes during the study period.
Detailed description
Patients after kidney tumor surgery (radical nephrectomy or partial nephrectomy) experience acute loss of functional nephrons, causing compensatory hyperfunction in remaining nephrons under overload conditions. This manifests as elevated glomerular filtration rate (hyperfiltration), increased plasma flow (hyperperfusion), and heightened capillary transmembrane pressure (hypertension), collectively termed the "three-high glomerular state," significantly increasing risks of Acute Kidney Injury(AKI) and long-term Chronic Kidney Disease(CKD). Chinese populations consume salt far exceeding WHO recommendations, with proven associations to hypertension, stroke, cardiovascular disease, kidney disease, and gastric cancer. High salt intake elevates CKD risk through two pathways: chronic high salt consumption induces hypertension (a key CKD risk factor), and activates renal renin-angiotensin-aldosterone system (RAAS), promoting inflammation, fibrosis, and oxidative stress-induced kidney damage-exacerbating the postoperative "three-high state" and further increasing CKD risk. Additionally, Asian populations frequently carry salt-sensitive genetic variants, where both salt sensitivity and high intake cause mineralocorticoid receptor overactivation, independently amplifying CKD susceptibility. Salt substitutes (potassium-enriched low-sodium salt, primarily NaCl and KCl) reduce sodium content versus regular salt, potentially improving renal hemodynamics by lowering sodium load and supplementing potassium to delay renal function decline. Recent multicenter RCTs and meta-analyses confirm cardiovascular benefits: the SSaSS trial demonstrated 13% reduced cardiovascular event risk with potassium-enriched salt (25% KCl), preventing ~460,000 cardiovascular deaths annually via blood pressure control and ~743,000 non-fatal cardiovascular events (including ~120,000 CKD cases) without significant hyperkalemia-related adverse events. The DECIDESalt trial showed significant blood pressure reductions (SBP: -7.1 mmHg; DBP: -1.9 mmHg) and lower cardiovascular risk with salt substitutes versus regular salt, with post hoc analysis indicating reduced hypertension incidence in normotensive individuals without inducing hypotension. Meta-analyses highlight amplified benefits in high-risk populations and Asian diets via sodium-potassium homeostasis and vascular improvement, with clinically insignificant mild potassium elevation confirming efficacy and safety. Despite these cardiovascular benefits, salt substitutes' renal safety and efficacy in post-nephrectomy patients remain unreported. Thus, the investigators propose this open-label randomized controlled trial to evaluate salt substitutes for postoperative renal protection in kidney tumor patients, establishing evidence-based dietary strategies for renal function preservation.
Therefore, the investigators plan to provide study participants with free salt substitute and standardized salt containers (5g) for one year. Participants will receive a one-month supply of free salt substitute upon hospital discharge. Adherence will be assessed at the one-month follow-up visit via 24-hour urine collection. Based on adherence confirmation, the next two-month supply of free salt substitute will be dispensed, continuing until the three-month follow-up.
This process will be repeated for subsequent phases: Adherence will be evaluated at discharge and each follow-up visit before dispensing the next phase's supply of free salt substitute.To enhance adherence during the extended interval between the 6-month and 12-month postoperative follow-ups: A telemedicine follow-up will be conducted at 9 months post-operation.Adherence will be assessed using a self-administered questionnaire, and the salt substitute will be remotely dispensed upon confirmation.
Non-adherence protocol:
First occurrence: Participants will receive intensive education reinforcing the importance of salt substitute use to improve adherence.
Recurrence: Participants will be discontinued from the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salt substitute | Experimental | Dietary Supplement: Salt substituteParticipants will consume salt substitutes |
| Common salt | No intervention | –Participants will consume Common salt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must meet all of the following criteria:
Key exclusion criteria (17 listed)
- Participants will be excluded if they meet any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salt substitutePatient consume salt substitutes daily while strictly adhering to WHO-recommendedsalt intake levels for 1 year.Salt substitutes (potassium-enriched low-sodium salt, primarily NaCl and KCl) reduce sodium content versus regular salt | Dietary supplement | Salt substitute |
Primary outcome
Estimated glomerular filtration rate (eGFR)
Time frame: Postoperative 12 months
Estimated glomerular filtration rate (eGFR) in kidney tumor patients at 12 months after surgery
7 secondary outcomes
Annual eGFR decline rate
Time frame: Postoperative 12 months
eGFR decline
Time frame: Postoperative 12 months
Reduction from baseline
Time frame: Postoperative 12 months
Incidence of adverse events
Time frame: Postoperative 12 months
Incidence of CKD progression
Time frame: Postoperative 12 months
Progression of proteinuria
Time frame: Postoperative 12 months
Quality of life questionnaire score
Time frame: Postoperative 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt substitute in people with Kidney Tumors and CKD, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qu Le M.D (+86 15720625951, septsoul@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated glomerular filtration rate (eGFR) (time frame: Postoperative 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.