Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction (RIPE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Peking University First Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01580046
First received: April 16, 2012
Last updated: October 14, 2013
Last verified: October 2013
  Purpose
The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.

Condition Intervention Phase
Kidney Failure, Chronic
Drug: iodixanol
Drug: iopromide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction—a Multicentre, Single Blind, Randomized Controlled, Prospective Trial

Resource links provided by NLM:


Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate [ Time Frame: days 3 and 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In each group(Iodixanol group and Iopromide group), the proportion of patients exhibiting an increases of serum creatinine in different range(<10%,10%~25%, and ≥25%), comparing with baseline level. [ Time Frame: days 3 and 7 ] [ Designated as safety issue: No ]
  • Incidence of hemodialysis [ Time Frame: days 3 and 7 ] [ Designated as safety issue: Yes ]
  • Changes of Cystatin C level from baseline [ Time Frame: days 1 and 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iodixanol Drug: iodixanol
  1. coronary angiography, 32gI/100ml, 40~60 ml once injection
  2. left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30~60 ml once injection
Active Comparator: iopromide Drug: iopromide
coronary angiography, 370mgI/ml(0.769gIopromide/ml),5~8 ml once injection
Other Name: Ultravist

Detailed Description:
The study is designed to compare renal toxicity of Iodixanol and Iopromide after coronary angiography or percutaneous coronary intervention (PCI) in patient with Chronic Kidney Disease, considering original renal function and adequate hydration. The risk of varying degree of renal impairment, changes of serum Cys C level will also be evaluated.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provides written Informed Consent and is willing to comply with protocol requirements
  • Is referred for cardiac angiography, with or without PCI
  • Has a documented predose serum creatinine level of 1.5~3.5 mg/dl for men and 1.3~3.0 mg/dl for women
  • Serum creatinine levels of twice tests conform with the baseline criteria, and the difference of twice serum creatinine tests is not more than 30%(first test: within 3 month,prior to enrollment; second test: at enrollment)

Exclusion Criteria:

  • Has a history of hypersensitivity to iodine-containing compounds
  • Has end-stage renal disease
  • Has kidney transplantation
  • Has creatinine clearance rates >60 ml/min in last 3 months
  • Has acute coronary syndrome with heart failure(above class II in accordance with Killip or class III in accordance with the classification of the New York Heart Association (NYHA)) and shock
  • Patients with cancer
  • Has diabetes with serious complications, other kidney organs
  • Patients with serious blood system disease
  • Heart failure [class III~Ⅳ in accordance with the classification of the New York Heart Association (NYHA) and (or) pulmonary edema]
  • Patients with hepatic insufficiency[3 times as ALT and (or) AST normal reference value limit]
  • Has received an iodinated contrast agent within 14 days prior to the administration of the study agent
  • Is scheduled to receive an iodinated contrast agent within 7 days after administration of the study agent
  • Has acute renal failure or end-stage renal disease requiring dialysis in the past 3 months
  • Use of 3 days continuously nonsteroidal anti-inflammatory drugs within 1 week of the procedure
  • Patients with hypotension [(SBP<80 mmHg for over 1h and needing Medication or intraaortic balloon counterpulsation(IABP) ]
  • Uncontrolled condition of hyperthyroidism
  • pregnancy or lactation
  • Is planned to receive the drugs without permission in this protocol
  • Participating in another intervention research study in last 3 months
  • legally incapacitated or limitations
  • Any other conditions not suitable to be enrollment
  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: NCT01580046

Locations
China, Anhui
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100044
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
China, Guangdong
Guangdong Academy Of Medical Sciences Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
China, Guangxi
The First Affiliated Hospital Of Guangxi Medical University
Nanning, Guangxi, China, 530021
China, Hebei
The People's Hospital Of Hebei Province
Shijiazhuang, Hebei, China, 050051
China, Henan
Henan Provincial People's Hospital
Luoyang, Henan, China, 450000
China, Jiangxi
The Second Affiliated Hospital To Nanchang University
Nanchang, Jiangxi, China, 330006
China, Liaoning
The People's Hospital Of Liaoning Province
Shenyang, Liaoning, China, 110016
China, Shandong
The Affiliated Hospital Of Medical College Qingdao University
Qingdao, Shandong, China, 266003
China, Shanxi
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China, 030024
China
Peking University People's Hospital
Beijing, China, 100044
Pla Navy General Hospital
Beijing, China, 100048
The Central Hospital Of China Aerospace Corporation
Beijing, China, 100049
Chinese PLA General Hospital
Beijing, China, 100853
Xinqiao Hospital, Third Military Medical University
Chongqing, China, 400037
Renji Hospital ,Shanghai Jiao Tong University School Of Medicine
Shanghai, China, 200001
Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University
Shanghai, China, 200030
Shanghai First People's Hospital
Shanghai, China, 200080
Sponsors and Collaborators
Yong Huo
  More Information

Responsible Party: Yong Huo, MD, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT01580046     History of Changes
Other Study ID Numbers: XNK201201 
Study First Received: April 16, 2012
Last Updated: October 14, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University First Hospital:
Chronic Kidney Disease
Coronary Angiography
Contrast Media
Percutaneous Coronary Intervention
Serum Creatinine
Glomerular Filtration Rate
Iodixanol
Iopromide

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on December 02, 2016