A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.

Department of Urology, Shanghai Xu-hui Central Hospital

The purpose of this study was to explore the effects of uric acid control on stone recurrence and renal function in patients with calculi of hyperuricemia through a prospective controlled study.

Study Overview

• Status: Unknown
• Conditions: Urolithiasis; Hypouricemia, Renal
• Intervention / Treatment: Drug: Febuxostat 40mg Tab; Behavioral: Non-drug control group

Detailed Description

2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). The patients were followed up for 3 months, 6 months, 12 months and 18 months after operation.

Informations as age, sex, height, weight, calculation BMI, past medical history, history of gout, diabetes, hyperthyroidism, calcium supplements will be recorded.

Rapid blood glucose, serum total cholesterol, high density cholesterol, thyroid hormone detection, androgen, estrogen detection, serum sodium, potassium, chlorine, calcium, magnesium, phosphorus, serum uric acid will be tested.

Renogram test to evaluate the change of single renal function. The stones burden will be followed-up with ultrasound or kub or CT plain scan.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• .Over 18 years old, under 70 years old, regardless of sex .The subjects had no mental illness or language dysfunction, could understand the situation of this study and had signed an informed consent form.

.No clinical manifestations of urinary tract infection, urinary routine examination showed urinary tract infection, but urinary etiology test was negative (urinary routine leukocytosis), treated with broad-spectrum antibiotics for more than 3 days.

.Clinical manifestations of urinary tract infection, urine routine examination showed urinary tract infection, and patients with positive urinary etiology were treated with sensitive antibiotics for more than 7 days.

• Serum uric acid value ≥480 µmol / L
• urinary stones

Exclusion Criteria:

• Transplanted kidney
• Fever or urinary tract infection is not treated according to the inclusion criteria
• Pregnant women and female menstruation
• Unable to tolerate anesthesia or surgery due to severe systemic disease, heart disease, pulmonary insufficiency and important organ failure
• Patients with renal insufficiency Clcr <30 mL/min
• Those who take side effects of febuxostat，Patients with side effects of febuxostat, patients with a previous history of coronary heart disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Uric acid drug control group; For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week	Drug: Febuxostat 40mg Tab; For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week.
Active Comparator: Non-drug control group; They are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly.	Behavioral: Non-drug control group; All patients in the group are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone burdern stone burdern	Use ultrasound or kub or CT plain scan to follow up the patients.	Change from the base line of the stone's volume and quantity at 3 months.
Stone burdern stone burdern	Use ultrasound or kub or CT plain scan to follow up the patients.	Change from the base line of the stone's volume and quantity at 6 months.
Stone burdern stone burdern	Use ultrasound or kub or CT plain scan to follow up the patients.	Change from the base line of the stone's volume and quantity at 12 months.
Stone burdern stone burdern	Use ultrasound or kub or CT plain scan to follow up the patients.	Change from the base line of the stone's volume and quantity at 18 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal function	Total and partial renal function	Change from the base line of GFR at 6 months after the operation.
Renal function	Total and partial renal function	Change from the base line of GFR at 12 months after the operation.
Renal function	Total and partial renal function	Change from the base line of GFR at 18 months after the operation.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum uric acid level	Serum uric acid level	Chage from the base line at 3 months after the operation
Serum uric acid level	Serum uric acid level	Chage from the base line at 6 months after the operation
Serum uric acid level	Serum uric acid level	Chage from the base line at 12 months after the operation
Serum uric acid level	Serum uric acid level	Chage from the base line at 18 months after the operation

Collaborators and Investigators

• Sponsor: Xuhui Central Hospital, Shanghai
• Investigators: Study Chair: JianMing Guo, PHD,M.D, Department of Urology, Zhongshan Hospital, Shanghai

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Febuxostat; Renal function; Stone prevention
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Urinary Calculi; Urolithiasis; Antirheumatic Agents; Gout Suppressants; Febuxostat
• Other Study ID Numbers: 2020-043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Subject information, test results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No