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The Prevention of Contrast Induced Nephropathy by Sarpogrelate in Patients With Chronic Kidney Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Seoul National University Boramae Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier:
NCT01165567
First received: July 19, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Drug: sarpogrelate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 4 Study of Sarpogrelate That Prevent Contrast-induced Nephropathy

Resource links provided by NLM:


Further study details as provided by Seoul National University Boramae Hospital:

Primary Outcome Measures:
  • incidence of contrast-induced nephropathy [ Time Frame: within 48 hours after using a contrast agent ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at 4 weeks after using a contrast agent ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 212
Study Start Date: December 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sarpogrelate 300 mg per day
Patients in the sarpogrelate group receive sarpogrelate 300 mg per day for 24 hours before exposure to contrast agent.
Drug: sarpogrelate
sarpogrelate, 300mg/day,duration: 4 weeks
Other Name: Anplag
No Intervention: No sarpogrelate medication

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165567

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Boramae Hospital
  More Information

No publications provided by Seoul National University Boramae Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul National University Boramae Hospital, Boramae Medical Center
ClinicalTrials.gov Identifier: NCT01165567     History of Changes
Other Study ID Numbers: 20091104/06-2009-123/89
Study First Received: July 19, 2010
Last Updated: July 19, 2010
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Sarpogrelate
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014