CClinicalTrials.gg
Sign In
Status unknownNCT01580046RIPEUpdated Oct 16, 2013

Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction

A Phase 4 interventional study of iodixanol and iopromide in Kidney Failure, Chronic, sponsored by Yong Huo. Status unknown at 19 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-10-16.

Sponsored by Yong Huo · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.

Read the 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.

02

Conditions studied

  • Kidney Failure, Chronic

Keywords

  • Chronic Kidney Disease
  • Coronary Angiography
  • Contrast Media
  • Percutaneous Coronary Intervention
  • Serum Creatinine
  • Glomerular Filtration Rate
  • Iodixanol
  • Iopromide
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 200 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Yong Huo is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Iodixanol

    Drug: iodixanol

  • Active comparator
    iopromide

    Drug: iopromide

Interventions

  • Drugiodixanol

    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

  • Drugiopromide

    coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection

    Also known as: Ultravist

06

What researchers measure

Primary outcomes

  1. to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate

    Time frame: days 3 and 7

Secondary outcomes

  1. 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

  2. Incidence of hemodialysis

    Time frame: days 3 and 7

  3. Changes of Cystatin C level from baseline

    Time frame: days 1 and 3

07

Study locations

6 of 19 sites recruiting
  • Anhui Provincial Hospital
    Hefei, Anhui 230001, China
    • Ji Yan, MD · Principal investigator
    • Kefu Feng, MD · Sub investigator
    Recruiting
  • Peking University First Hospital
    Beijing, Beijing 100044, China
    • Yong Huo, MD · Principal investigator
    • Zhaoping Liu, MD · Sub investigator
    Recruiting
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
    • Lianglong Chen, MD · Principal investigator
    • Xingchun Zheng, MD · Sub investigator
    Not yet recruiting
  • Guangdong Academy Of Medical Sciences Guangdong General Hospital
    Guangzhou, Guangdong 510080, China
    • Jiyan Chen, MD · Principal investigator
    • Yong Liu, MD · Sub investigator
    Not yet recruiting
  • The First Affiliated Hospital Of Guangxi Medical University
    Nanning, Guangxi 530021, China
    • Lang Li, MD · Principal investigator
    • Xiaocong Zeng, MD · Sub investigator
    Recruiting
  • The People's Hospital Of Hebei Province
    Shijiazhuang, Hebei 050051, China
    • Xiaoyong Qi, MD · Principal investigator
    • Tianhong Wang, MD · Sub investigator
    Not yet recruiting
  • Henan Provincial People's Hospital
    Luoyang, Henan 450000, China
    • Chuanyu Gao, MD · Principal investigator
    Not yet recruiting
  • The Second Affiliated Hospital To Nanchang University
    Nanchang, Jiangxi 330006, China
    • Xiaoshu Cheng, MD · Principal investigator
    • Yanqing Wu, MD · Sub investigator
    Not yet recruiting
  • The People's Hospital Of Liaoning Province
    Shenyang, Liaoning 110016, China
    • Zhanquan Li, MD · Principal investigator
    • Yongxin Wang, MD · Sub investigator
    Recruiting
  • The Affiliated Hospital Of Medical College Qingdao University
    Qingdao, Shandong 266003, China
    • Yi An, MD · Principal investigator
    • Hua Yu, MD · Sub investigator
    Not yet recruiting
  • Shanxi Cardiovascular Hospital
    Taiyuan, Shanxi 030024, China
    • Bao Li, MD · Principal investigator
    • Zhongchao Wang, MD · Sub investigator
    Not yet recruiting
  • Peking University People's Hospital
    Beijing, 100044, China
    • Weimin Wang, MD · Principal investigator
    Not yet recruiting
  • Pla Navy General Hospital
    Beijing, 100048, China
    • Tianchang Li, MD · Principal investigator
    Recruiting
  • The Central Hospital Of China Aerospace Corporation
    Beijing, 100049, China
    • Bin Wang, MD · Principal investigator
    • Tao Qu, MD · Sub investigator
    • Ying Shen, MD · Sub investigator
    Recruiting
  • Chinese PLA General Hospital
    Beijing, 100853, China
    • Yundai Chen, MD · Principal investigator
    • Wei Dong, MD · Sub investigator
    • Sunying Hu, MD · Sub investigator
    Not yet recruiting
  • Xinqiao Hospital, Third Military Medical University
    Chongqing, 400037, China
    • Lan Huang, MD · Principal investigator
    • Jun Jin, MD · Sub investigator
    • Yun He, MD · Sub investigator
    Not yet recruiting
  • Renji Hospital ，Shanghai Jiao Tong University School Of Medicine
    Shanghai, 200001, China
    • Ben He, MD · Principal investigator
    Not yet recruiting
  • Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University
    Shanghai, 200030, China
    • Weiyi Fang, MD · Principal investigator
    Not yet recruiting
  • Shanghai First People's Hospital
    Shanghai, 200080, China
    • Shaowen Liu, MD · Principal investigator
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01580046
Lead sponsor
Yong Huo
Responsible party
Yong Huo (MD, Peking University First Hospital) — Sponsor-investigator
First posted
Apr 18, 2012
Start date
Apr 2012
Primary completion
Dec 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Oct 16, 2013

Study contacts

Zhaoping Liu, MD
Contact
dr_liuzhp@yahoo.com.cn
86-10-83575727

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Renal Insufficiency→

Other studies from this sponsor

Yong Huo

Start the discussion