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A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence

Primary Purpose

Urolithiasis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Potassium Citrate Extended-release Tablets
Sponsored by
Dawnrays Pharmaceutical (Holdings) Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urolithiasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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;
  • 18-70 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • The Fifth Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • The Second Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • Wuhan No.1 Hospital(Wuhan Integrated TCM & Western Medicine Hospital)
  • Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of MedicineRecruiting
  • Zhejiang Xiaoshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Blank control group

Arm Description

Potassium Citrate Extended-release Tablets

Subjects do not take the investigational product

Outcomes

Primary Outcome Measures

Rate of Urolithiasis recurrence

Secondary Outcome Measures

Time of stone recurrence
The changes of urine citric acid content compared with baseline
The changes of Urine pH value compared with baseline

Full Information

First Posted
December 13, 2016
Last Updated
January 31, 2018
Sponsor
Dawnrays Pharmaceutical (Holdings) Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03007160
Brief Title
A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
Official Title
A Randomized, Blank Controlled, Multicenter Clinical Trial of the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dawnrays Pharmaceutical (Holdings) Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence.
Detailed Description
This study takes "Rate of stone recurrence" as primary outcome measure, by random, blank control, and multicenter clinical trial design method, assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence, provide evidence for drug re-registration, and observe its efficacy on Urinary calculi such as renal tubular acidosis with calcium stone, and uric acid stones with or without calcium stone, urinary tract stone of effectiveness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2001 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Potassium Citrate Extended-release Tablets
Arm Title
Blank control group
Arm Type
No Intervention
Arm Description
Subjects do not take the investigational product
Intervention Type
Drug
Intervention Name(s)
Potassium Citrate Extended-release Tablets
Other Intervention Name(s)
Juyuansuanjia Huanshi Pian
Intervention Description
Daily 3.24g, Po ,Tid, each 1.08g/tablets
Primary Outcome Measure Information:
Title
Rate of Urolithiasis recurrence
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Time of stone recurrence
Time Frame
through study completion, an average of 1 year
Title
The changes of urine citric acid content compared with baseline
Time Frame
through study completion, an average of 1 year
Title
The changes of Urine pH value compared with baseline
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 18-70 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhangqun YE, M.D.
Phone
(+86)13507191761
Email
zhangqun_ye@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhangqun YE, M.D.
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fifth Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dehui LAI
Phone
(+86)13570508863
Email
dehuilai@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yongzhong HE
First Name & Middle Initial & Last Name & Degree
Dehui LAI
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changwei LIU
Phone
(+86)13526709425
Email
lcw8001@126.com
First Name & Middle Initial & Last Name & Degree
Changbao XU
First Name & Middle Initial & Last Name & Degree
Changwei LIU
Facility Name
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolin GUO, M.D.
Phone
(+86)13886042051
Email
guoxiaolin0488@sina.com
First Name & Middle Initial & Last Name & Degree
Zhangqun YE, M.D.
First Name & Middle Initial & Last Name & Degree
Xiaolin GUO, M.D.
Facility Name
Wuhan No.1 Hospital(Wuhan Integrated TCM & Western Medicine Hospital)
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingxi XU
Phone
(+86)18221683312
Email
xuhuaneric@126.com
First Name & Middle Initial & Last Name & Degree
Zhong WANG
First Name & Middle Initial & Last Name & Degree
Mingxi XU
Facility Name
Zhejiang Xiaoshan Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xing WANG
Phone
(+86)18058806706
Email
fly115135@sohu.com
First Name & Middle Initial & Last Name & Degree
Yi FAN
First Name & Middle Initial & Last Name & Degree
Xing WANG

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25881654
Citation
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.
Results Reference
background
PubMed Identifier
12028622
Citation
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.
Results Reference
background
PubMed Identifier
10210371
Citation
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.
Results Reference
background
PubMed Identifier
20576821
Citation
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.
Results Reference
background
PubMed Identifier
17726345
Citation
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.
Results Reference
background

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A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence

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