The Prevention of Contrast Induced Nephropathy by Sarpogrelate in Patients With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
sarpogrelate
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- patient with chronic kidney disease scheduled for coronary angiogram
Exclusion Criteria:
- age less than 20 years or more than 85 years
- liver cirrhosis greater than or equal to Child class B
- decreased serum platelet level (< 100,000/uL)
- patients who received or are schedule to receive percutaneous renal intervention
- currently are taking anticoagulation drugs
- unable to give informed consent
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
sarpogrelate 300 mg per day
No sarpogrelate medication
Arm Description
Patients in the sarpogrelate group receive sarpogrelate 300 mg per day for 24 hours before exposure to contrast agent.
Outcomes
Primary Outcome Measures
incidence of contrast-induced nephropathy
The primary outcome of the study is the incidence of CIN, defined as either a greater than 25 percent increase of serum Cr or an absolute increase in serum Cr of 0.5 mg/dL within 48 hours after using a contrast agent
Secondary Outcome Measures
occurrence of CIN
Clinical endpoint measurements are conducted in-hospital and at 4 weeks. Cr concentration is measured at admission, every day for the next two days after contrast exposure, and at 4 weeks
Full Information
NCT ID
NCT01165567
First Posted
July 19, 2010
Last Updated
July 19, 2010
Sponsor
Seoul National University Boramae Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01165567
Brief Title
The Prevention of Contrast Induced Nephropathy by Sarpogrelate in Patients With Chronic Kidney Disease
Official Title
Phase 4 Study of Sarpogrelate That Prevent Contrast-induced Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Boramae Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background:
Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hydration with saline are being prescribed to prevent renal deterioration in these high risk patients, their efficacy is not clear defined and debatable. Therefore additional prophylactic pretreatments are needed.
Methods/Design:
Present study aims to investigate differences in occurrence of CIN after sarpogrelate premedication in patients with chronic kidney disease (CKD). 268 participants, aged 20-85 years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to one of two conditions: (i) a routine treatment without sarpogrelate group (ii) routine treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day). The primary outcome is the occurrence of CIN during 4 weeks after receiving contrast agent.
Discussion:
As of May 2010, there were no registered trials evaluating the therapeutic potentials of sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal function and occurrence of CIN, it will provide a safe, easy and inexpensive treatment option.
Detailed Description
All patients with CKD scheduled for CAG will be eligible, assuming their ability to understand the character and individual consequences of participation as well as giving written informed consent. CKD is defined as estimated glomerular filtration rate (eGFR) <60 mL/min per 1.73 m2 using modification of diet in renal disease (MDRD) formula or serum creatinine (Cr) > 1.5 mg/dL.
The MDRD formula was defined in the following way. Where the Cr concentration is in mg/dL:
eGFR = 186 × serum Cr-1.154 × Age-0.203 × (0.742 if female) Exclusion criteria are age less than 20 years or more than 85 years, liver cirrhosis greater than or equal to Child class B, decreased serum platelet level (< 100,000/uL), patients who received or are schedule to receive percutaneous renal intervention, currently are taking anticoagulation drugs, unable to give informed consent. Patients in shock, maintaining hemodialysis, hemofiltration, peritoneal dialysis will be excluded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sarpogrelate 300 mg per day
Arm Type
Experimental
Arm Description
Patients in the sarpogrelate group receive sarpogrelate 300 mg per day for 24 hours before exposure to contrast agent.
Arm Title
No sarpogrelate medication
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
sarpogrelate
Other Intervention Name(s)
Anplag
Intervention Description
sarpogrelate, 300mg/day,duration: 4 weeks
Primary Outcome Measure Information:
Title
incidence of contrast-induced nephropathy
Description
The primary outcome of the study is the incidence of CIN, defined as either a greater than 25 percent increase of serum Cr or an absolute increase in serum Cr of 0.5 mg/dL within 48 hours after using a contrast agent
Time Frame
within 48 hours after using a contrast agent
Secondary Outcome Measure Information:
Title
occurrence of CIN
Description
Clinical endpoint measurements are conducted in-hospital and at 4 weeks. Cr concentration is measured at admission, every day for the next two days after contrast exposure, and at 4 weeks
Time Frame
at 4 weeks after using a contrast agent
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient with chronic kidney disease scheduled for coronary angiogram
Exclusion Criteria:
age less than 20 years or more than 85 years
liver cirrhosis greater than or equal to Child class B
decreased serum platelet level (< 100,000/uL)
patients who received or are schedule to receive percutaneous renal intervention
currently are taking anticoagulation drugs
unable to give informed consent
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
35224730
Citation
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Results Reference
derived
PubMed Identifier
31625293
Citation
Ki YJ, Kwon SA, Kim HL, Seo JB, Chung WY. The Prevention of Contrast Induced Nephropathy by Sarpogrelate: a Prospective Randomized Controlled Clinical Trial. J Korean Med Sci. 2019 Oct 21;34(40):e261. doi: 10.3346/jkms.2019.34.e261.
Results Reference
derived
PubMed Identifier
21167080
Citation
Park K, Chung WY, Seo JB, Kim SH, Zo JH, Kim MA, Park YB. The prevention of contrast induced nephropathy by sarpogrelate in patients with chronic kidney disease: a study protocol for a prospective randomized controlled clinical trial. Trials. 2010 Dec 20;11:122. doi: 10.1186/1745-6215-11-122.
Results Reference
derived
Learn more about this trial
The Prevention of Contrast Induced Nephropathy by Sarpogrelate in Patients With Chronic Kidney Disease
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