NCT04352153

Brief Summary

The purpose of the study is to provide a more direct and objective basis for the widespread use of potassium sodium hydrogen citrate granules in the treatment of uric acid stones.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

April 10, 2020

Last Update Submit

April 16, 2020

Conditions

Uric Acid StonesHyperuricemia

Keywords

Uric Acid StonesHyperuricemiaUralyt-U

Outcome Measures

Primary Outcomes (2)

  • Uric acid stones

    Uric acid stones will be estimated by dual-source CT examination

    3 months

  • Uric acid stones

    Uric acid stones will be estimated by dual-source CT examination

    6 months

Secondary Outcomes (3)

  • Blood uric acid

    1 month

  • Blood uric acid

    3 months

  • Blood uric acid

    6 months

Study Arms (2)

Single-use group

EXPERIMENTAL

Febuxostat is taken at a dose of 20 mg once a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.

Drug: Febuxostat

Research group

EXPERIMENTAL

Febuxostat is taken at a dose of 20 mg once a day, potassium sodium hydrogen citrate granules 7.5 g / day, 2.5 g / per time, three times a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.

Drug: FebuxostatDrug: Uralyt-U

Interventions

FebuxostatDRUG

Febuxostat is taken at a dose of 20 mg once a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.

Also known as: Uloric, Adenuric
Research groupSingle-use group
Uralyt-UDRUG

Febuxostat is taken at a dose of 20 mg once a day, potassium sodium hydrogen citrate granules 7.5 g / day, 2.5 g / per time, three times a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.

Also known as: potassium sodium hydrogen citrate granules
Research group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old, male, outpatient or inpatient;
  • Acidic urinary stones
  • Serum uric acid value ≥480 µmol / L;
  • Other concomitant diseases (such as hypertension, hyperlipidemia, diabetes, etc.) are in a stable condition, and the dosage of other diseases is not changed during the test.
  • eGFR≥30ml / min;

You may not qualify if:

  • Pregnant or lactating women;
  • Patients with acute or chronic renal failure (eGFR \<30ml / min);
  • Patients with severe liver dysfunction (ALT, AST≥70 IU);
  • In patients with uncontrolled hypertension, systolic blood pressure ≥160 and / or diastolic blood pressure ≥110mmHg;
  • In uncontrolled diabetic patients, fasting blood glucose is\> 10mmol / L, and / or glycated hemoglobin is ≥9%;
  • Patients that are taking atorvastatin, losartan, amlodipine, fenofibrate, pyrazinamide, tincture diuretics, thiazide diuretics, glucocorticoids, immunosuppressive agents and other drugs that affect uric acid excretion Drugs, those taking aspirin at a dose of\> 325mg / day;
  • Cancer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrolgoy, Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (1)

  • Xue W, Cheng J, Zhao J, Wang L, Peng A, Liu X. Comparison potassium sodium hydrogen citrate with sodium bicarbonate in urine alkalization: a prospective crossover-controlled trial. Int Urol Nephrol. 2023 Jan;55(1):61-68. doi: 10.1007/s11255-022-03387-y. Epub 2022 Oct 19.

    PMID: 36261757DERIVED

MeSH Terms

Conditions

Hyperuricemia

Interventions

FebuxostatCitrates

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTricarboxylic AcidsAcids, AcyclicCarboxylic Acids

Study Officials

  • Ai Peng, Ph.D., M.D.

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ai Peng, Ph.D., M.D.

CONTACT

86-21-66302524pengai@tongji.edu.cn

Jiafen Cheng, M.D.

CONTACT

86-21-66302527chengjiafen@tongji.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of the department of Nephrology, Shanghai 10th people's hospital

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 20, 2020

Study Start

April 1, 2020

Primary Completion

September 30, 2020

Study Completion

October 31, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)