Acute Kidney InjuryPhase 4NCT01978405
Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes
A Phase 4 study testing Alpha lipoic acid in people with Acute Kidney Injury and The Changes of Plasma Creatinine, run by Xiang Guang-da at 1 site in China.
Trial summary
Contrast-induced acute kidney injury (CIAKI) is a major complication with adverse outcomes after contrast media injection. Although the risk of developing CIAKI is low in patients with normal renal function, it is dramatically higher in patients with conditions such as diabetes mellitus (DM) or chronic kidney disease… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Acute Kidney Injury, The Changes of Plasma Creatinine, The Changes of Plasma Free Radicals
- What is being tested?
- Alpha lipoic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- nephropathy (stage 3 and 4)
Who cannot join
- recive alpha lipoic acid
- type 1 diabetes
- nephropathy (stagte 1, 2 and 5)
- hypersensitivity to contrast media
- IV heart failure
- lactic acidosis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan General Hospital
Wuhan, Hubei, 430070
Xiang Guangda, MD, +8602768878410
About this study
Contrast-induced acute kidney injury (CIAKI) is a major complication with adverse outcomes after contrast media injection. Although the risk of developing CIAKI is low in patients with normal renal function, it is dramatically higher in patients with conditions such as diabetes mellitus (DM) or chronic kidney disease (CKD). More recently, our data showed that contrast agents can induce endothelial dysfunction partially via free radicals in diabetes. Therefore, strategies to prevent CIAKI and endothelial dysfunction in DM patients with CKD are urgently needed. Alpha-lipoic acid and its reduced form, dihydrolipoate, are potent antioxidants. We hypothesized that alpha lipoic acid can prevent the contrast-induced acute kidney injury and endothelial dysfunction in type 2 diabetes.
- Conditions
- Acute Kidney Injury, The Changes of Plasma Creatinine, The Changes of Plasma Free Radicals, The Changes of Endothelium-dependent Arterial Dilation
- Being tested
- Alpha lipoic acid
- Keywords
- Type 2 diabetes, Nephropathy, Contrast medium, Alpha lipoic acid
- Medical subject headings
- Acute Kidney Injury, Diabetes Mellitus, Type 2, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha lipoic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| alpha-lipoic acid group | Experimental | Alpha lipoic acid 600 mg in 0.9% sodium chloride 250 ml was given before and after contrast agent was administrated. Receives: Drug: Alpha lipoic acid |
| Placebo intervention group | Placebo comparator | Only 0.9% sodium chloride 250 ml was given for this group. Receives: Drug: Alpha lipoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast induced acte kidney injury
Measured: 6 months
The changes of endothelium-dependent arterial dilation before and after contrast administrated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang Guang-da
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiang Guang-da, Wuhan General Hospital of Guangzhou Military Command
- Investigators
- Xiang Guangda, MD, Study director, Wuhan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978405
- Sponsor's protocol ID
- 2013Wze088
- Status last verified
- Oct 2013
- First submitted
- 25 Oct 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01978405
- Acronym / sponsor ID
- 2013Wze088
- Conditions
- Acute Kidney Injury, The Changes of Plasma Creatinine, The Changes of Plasma Free Radicals, The Changes of Endothelium-dependent Arterial Dilation
- Keywords
- Type 2 diabetes, Nephropathy, Contrast medium, Alpha lipoic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xiang Guang-daUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Contrast-induced acute kidney injury (CIAKI) is a major complication with adverse outcomes after contrast media injection. Although the risk of developing CIAKI is low in patients with normal renal function, it is dramatically higher in patients with conditions such as diabetes mellitus (DM) or chronic kidney disease (CKD). More recently, our data showed that contrast agents can induce endothelial dysfunction partially via free radicals in diabetes. Therefore, strategies to prevent CIAKI and endothelial dysfunction in DM patients with CKD are urgently needed. Alpha-lipoic acid and its reduced form, dihydrolipoate, are potent antioxidants. We hypothesized that alpha lipoic acid can prevent the contrast-induced acute kidney injury and endothelial dysfunction in type 2 diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alpha-lipoic acid group | Experimental | Drug: Alpha lipoic acidAlpha lipoic acid 600 mg in 0.9% sodium chloride 250 ml was given before and after contrast agent was administrated. |
| Placebo intervention group | Placebo comparator | Drug: Alpha lipoic acidOnly 0.9% sodium chloride 250 ml was given for this group. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetes
- nephropathy (stage 3 and 4)
Key exclusion criteria (6 listed)
- recive alpha lipoic acid
- type 1 diabetes
- nephropathy (stagte 1, 2 and 5)
- hypersensitivity to contrast media
- IV heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha lipoic acid | Drug | Placebo intervention group, alpha-lipoic acid group |
Primary outcome
Contrast induced acte kidney injury
Time frame: 6 months
The changes of endothelium-dependent arterial dilation before and after contrast administrated
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiang Guangda, MD study director
Wuhan General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alpha lipoic acid in people with Acute Kidney Injury and The Changes of Plasma Creatinine, run by Xiang Guang-da at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Guangda, MD (+8602768878410, Guangda64@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast induced acte kidney injury (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2013.