NCT03007160

Brief Summary

Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence.

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
2,001

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2016

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

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

July 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

4.2 years

First QC Date

December 13, 2016

Last Update Submit

January 31, 2018

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

  • Rate of Urolithiasis recurrence

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • Time of stone recurrence

    through study completion, an average of 1 year

  • The changes of urine citric acid content compared with baseline

    through study completion, an average of 1 year

  • The changes of Urine pH value compared with baseline

    through study completion, an average of 1 year

Study Arms (2)

Experimental group

EXPERIMENTAL

Potassium Citrate Extended-release Tablets

Drug: Potassium Citrate Extended-release Tablets

Blank control group

NO INTERVENTION

Subjects do not take the investigational product

Interventions

Potassium Citrate Extended-release TabletsDRUG

Daily 3.24g, Po ,Tid, each 1.08g/tablets

Also known as: Juyuansuanjia Huanshi Pian
Experimental group

Eligibility Criteria

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

You may qualify if:

  • Patients with upper urinary tract calculi surgery and/or ESWL within 3 months；
  • Stone free or had residual stone fragments with a less than 4 mm diamete；
  • years of age; the gender is not limited；
  • Agree to take effective contraceptive measures during the study period, and female of childbearing age whose pregnancy test is negative；
  • Subjects with no mental illness and language dysfunction, can understand the situation of the study and have signed informed consent.

You may not qualify if:

  • Patients with infectious stones, medical stones and urinary tract obstruction；
  • Patients with hyperkalemia (K+\>5.5mmol/L) (or patients with factors or disease that can cause hyperkalemia), because the further increase in blood potassium can lead to cardiac arrest. These factors include disease or strenuous exercise, chronic renal failure, uncontrolled diabetes, acute dehydration, excessive, adrenal insufficiency, extensive tissue failure. Patients who takes potassium sparing diuretics (such as triamterene, spironolactone, amiloride)；
  • Patients with gastrointestinal disorders, such as peptic ulcer, severe vomiting, diarrhea, delayed gastric emptying, intestinal obstruction, etc.；
  • Combined with cardiovascular, liver, kidney, hematopoietic system, such as severe primary disease, or known to affect the survival of serious diseases (such as cancer or AIDS), or patients with with disabilities mentally or legally；
  • Patients with renal insufficiency (1.2 times the upper limit of the normal value of serum creatinine and urea nitrogen)；
  • The recent (within 6 months) with family planners；
  • Allergic to this product；
  • To participate in other clinical trials in the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Wuhan No.1 Hospital（Wuhan Integrated TCM & Western Medicine Hospital）

Wuhan, Hubei, China

ACTIVE NOT RECRUITING

Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (5)

  • Sfoungaristos S, Gofrit ON, Yutkin V, Pode D, Duvdevani M. Prevention of renal stone disease recurrence. A systematic review of contemporary pharmaceutical options. Expert Opin Pharmacother. 2015 Jun;16(8):1209-18. doi: 10.1517/14656566.2015.1037740. Epub 2015 Apr 16.

    PMID: 25881654BACKGROUND

  • Soygur T, Akbay A, Kupeli S. Effect of potassium citrate therapy on stone recurrence and residual fragments after shockwave lithotripsy in lower caliceal calcium oxalate urolithiasis: a randomized controlled trial. J Endourol. 2002 Apr;16(3):149-52. doi: 10.1089/089277902753716098.

    PMID: 12028622BACKGROUND

  • Lee YH, Huang WC, Tsai JY, Huang JK. The efficacy of potassium citrate based medical prophylaxis for preventing upper urinary tract calculi: a midterm followup study. J Urol. 1999 May;161(5):1453-7.

    PMID: 10210371BACKGROUND

  • Fabris A, Lupo A, Bernich P, Abaterusso C, Marchionna N, Nouvenne A, Gambaro G. Long-term treatment with potassium citrate and renal stones in medullary sponge kidney. Clin J Am Soc Nephrol. 2010 Sep;5(9):1663-8. doi: 10.2215/CJN.00220110. Epub 2010 Jun 24.

    PMID: 20576821BACKGROUND

  • Bartoletti R, Cai T, Mondaini N, Melone F, Travaglini F, Carini M, Rizzo M. Epidemiology and risk factors in urolithiasis. Urol Int. 2007;79 Suppl 1:3-7. doi: 10.1159/000104434.

    PMID: 17726345BACKGROUND

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Zhangqun YE, M.D.

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhangqun YE, M.D.

CONTACT

(+86)13507191761zhangqun_ye@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2016

First Posted

January 2, 2017

Study Start

July 1, 2016

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(6)