Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery

NCT07062952 | Recruiting

• 1 other identifier: 2025DZKY-068-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. lt will alsoassess the feasibility of salt substitute intervention. The primary research questions are:

1. 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. 2.What is the safety profile of salt substitute intervention in postoperative kidney tumor patients?
3. 3.What is the compliance rate among postoperative kidney tumor patients using saltsubstitutes?
4. 4.ls the salt substitute intervention feasible?
5. 5.Consume salt substitutes or regular salt daily while strictly adhering to WHO-recommendedsalt intake levels for 1 year.
6. 6.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.
7. 7.Receive regular monitoring of blood electrolytes, eGFR, and other renal function indicators.
8. 8.Document any adverse events or health status changes during the study period.

Conditions

Kidney Tumors; CKD; Salt Substitute; Nephrectomy; eGFR

Keywords

kidney tumor; CKD; Salt substitute; nephrectomy; eGFR; kidney protection; kidney function; open-label; randomized controlled trial; Renal function compensation; CKD with clinical significance

Outcome Measures

Primary Outcomes (1)

• Estimated glomerular filtration rate (eGFR)

  Estimated glomerular filtration rate (eGFR) in kidney tumor patients at 12 months after surgery

  Postoperative 12 months

Secondary Outcomes (7)

• Annual eGFR decline rate

  Postoperative 12 months

• eGFR decline

  Postoperative 12 months

• Reduction from baseline

  Postoperative 12 months

• Incidence of adverse events

  Postoperative 12 months

• Incidence of CKD progression

  Postoperative 12 months

Study Arms (2)

Salt substitute

EXPERIMENTAL

Participants will consume salt substitutes

Dietary Supplement: Salt substitute

Common salt

NO INTERVENTION

Participants will consume Common salt

Interventions

Salt substitute DIETARY_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

Salt substitute

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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:

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Qu Le M.D

CONTACT

+86 15720625951; septsoul@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief urologist

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 14, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CN (1)