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

NCT01165567 | Unknown Phase 4

• 1 other identifier: 20091104/06-2009-123/89
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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

  within 48 hours after using a contrast agent

Secondary Outcomes (1)

• occurrence of CIN

  at 4 weeks after using a contrast agent

Study Arms (2)

sarpogrelate 300 mg per day

EXPERIMENTAL

Patients in the sarpogrelate group receive sarpogrelate 300 mg per day for 24 hours before exposure to contrast agent.

Drug: sarpogrelate

No sarpogrelate medication

NO INTERVENTION

Interventions

sarpogrelate DRUG

sarpogrelate, 300mg/day,duration: 4 weeks

Also known as: Anplag

sarpogrelate 300 mg per day

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with chronic kidney disease scheduled for coronary angiogram

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Boramae Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 156-707, South Korea

Location

Related Publications (3)

• 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.

  PMID: 35224730 DERIVED

• 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.

  PMID: 31625293 DERIVED

• 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.

  PMID: 21167080 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

sarpogrelate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 20, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 20, 2010

Record last verified: 2010-07

Locations

KR (1)