Hemodialysis Access FailurePhase 2NCT03524846
Ascorbic Acid on Restenosis of Dysfunctional Hemodialysis Vascular Access
A Phase 2 study testing Ascorbic Acid 300 MG, Ascorbic Acid 600 MG and Normal saline in people with Hemodialysis Access Failure, run by National Taiwan University Hospital Hsin-Chu Branch.
Trial summary
To investigate the effect of ascorbic acid on angiographic restenosis after percutaneous transluminal angioplasty (PTA) for dysfunctional dialysis vascular access. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemodialysis Access Failure
- What is being tested?
- Ascorbic Acid 300 MG, Ascorbic Acid 600 MG and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Oct 2011
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical signs, i.e., decreased thrill, development of collateral veins, limb swelling, and prolonged bleeding from puncture sites, suggesting vascular access dysfunction
- reduction of flow rate more than 25% from baseline
- total access blood flow rate less than 500 mL/min by ultrasound dilution method
- increased venous pressure during dialysis, as dynamic venous pressure exceeding threshold levels of 150 mmHg in AVF and 160 mmHg in AVG, respectively, under dialysis blood flow 250 ml/min for three consecutive times
Who cannot join
- hospitalized for infection, heart failure, or acute coronary syndrome in recent 3 months
- unable to comply with follow-up visits
- already under ascorbic acid or other antioxidant supplements
About this study
Official title: Effect of Ascorbic Acid Administration on Restenosis of Dysfunctional Hemodialysis Vascular
To investigate the effect of ascorbic acid on angiographic restenosis after percutaneous transluminal angioplasty (PTA) for dysfunctional dialysis vascular access.
Read the detailed description
Vascular access dysfunction is the leading cause of treatment insufficiency or interruption among hemodialysis (HD) patients, and it is responsible for a large portion of the cost of any end-stage renal disease (ESRD) program. Intimal hyperplasia at the venous segment of vascular access is the characteristic lesion, which leads to dysfunction or failure of both arteriovenous fistulas (AVF) and prosthetic grafts (AVG). Although percutaneous transluminal angioplasty (PTA) is effective in treating these stenotic lesions, the effect seems not permanent and restenosis after PTA remains a major problem. A number of studies have examined the clinical, anatomical, and technical factors for restenosis, the causes of restenosis are still not fully understood.This highlights a possible role of non-traditional risk factors to explain the high restenosis rate at the venous segment of vascular access, which includes oxidative stress, inflammation, and endothelial dysfunction.
Ascorbic acid (vitamin C) is a potent antioxidant used for a long time. Hemodialysis patients had been shown to be deficient in antioxidant defense, which resulted in increasing requirement of ascorbic acid supplement. Currently, intravenous 300-mg ascorbic acid supplementation three times a week after hemodialysis had been used to overcome erythropoietin resistance in patients with iron deficiency. Theoretically, ascorbic acid scavenges reactive oxygen species and reactive nitrogen species and may thereby prevent oxidative injuries. Investigators reported that administration of high dose ascorbic acid could prevent lipid peroxidation and oxidative DNA damage in patients with ESRD.
In this study, the investigators investigated whether ascorbic acid could decrease venous restenosis after PTA for dysfunctional hemodialysis vascular access.
- Conditions
- Hemodialysis Access Failure
- Being tested
- Ascorbic Acid 300 MG, Ascorbic Acid 600 MG, Normal saline
- Keywords
- Ascorbic acid, hemodialysis vascular access, restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic Acid 300 MGDrug
Also called Vitamin C
Ascorbic acid 300 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.
Ascorbic Acid 600 MGDrug
Also called Vitamin C
Ascorbic acid 600 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.
Normal salineDrug
Normal saline was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic acid 300 mg | Active comparator | Ascorbic acid 300 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks. Receives: Drug: Ascorbic Acid 300 MG |
| Ascorbic acid 600 mg | Active comparator | Ascorbic acid 600 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks. Receives: Drug: Ascorbic Acid 600 MG |
| Placebo | Placebo comparator | Normal saline was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the extent of restenosis after angioplasty
the extent of restenosis defined by the late loss of minimal vessel diameter and late loss of percentage stenosis at follow-up angiograms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis Access FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a prospective randomized, single-blind, placebo-controlled study
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch
- Investigators
- Chih-Cheng Wu, M.D., Study director, Associate professor of Medicine, National Taiwan University, College of Medicine, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524846
- Sponsor's protocol ID
- 99G002
- Status last verified
- May 2018
- First submitted
- 30 Apr 2018
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tomoda H, Yoshitake M, Morimoto K, Aoki N. Possible prevention of postangioplasty restenosis by ascorbic acid. Am J Cardiol. 1996 Dec 1;78(11):1284-6. doi: 10.1016/s0002-9149(96)00613-3.
PubMed 8960592Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
PubMed 37916745Yang CW, Wu CC, Luo CM, Chuang SY, Chen CH, Shen YF, Tarng DC. A randomized feasibility study of the effect of ascorbic acid on post-angioplasty restenosis of hemodialysis vascular access (NCT03524846). Sci Rep. 2019 Jul 31;9(1):11095. doi: 10.1038/s41598-019-47583-w.
PubMed 31366980
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ascorbic Acid Administration on Restenosis of Dysfunctional Hemodialysis Vascular
- ClinicalTrials.gov ID
- NCT03524846
- Acronym / sponsor ID
- 99G002
- Conditions
- Hemodialysis Access Failure
- Keywords
- Ascorbic acid, hemodialysis vascular access, restenosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 May 2018 (actual)
- 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.
To investigate the effect of ascorbic acid on angiographic restenosis after percutaneous transluminal angioplasty (PTA) for dysfunctional dialysis vascular access.
Detailed description
Vascular access dysfunction is the leading cause of treatment insufficiency or interruption among hemodialysis (HD) patients, and it is responsible for a large portion of the cost of any end-stage renal disease (ESRD) program. Intimal hyperplasia at the venous segment of vascular access is the characteristic lesion, which leads to dysfunction or failure of both arteriovenous fistulas (AVF) and prosthetic grafts (AVG). Although percutaneous transluminal angioplasty (PTA) is effective in treating these stenotic lesions, the effect seems not permanent and restenosis after PTA remains a major problem. A number of studies have examined the clinical, anatomical, and technical factors for restenosis, the causes of restenosis are still not fully understood.This highlights a possible role of non-traditional risk factors to explain the high restenosis rate at the venous segment of vascular access, which includes oxidative stress, inflammation, and endothelial dysfunction.
Ascorbic acid (vitamin C) is a potent antioxidant used for a long time. Hemodialysis patients had been shown to be deficient in antioxidant defense, which resulted in increasing requirement of ascorbic acid supplement. Currently, intravenous 300-mg ascorbic acid supplementation three times a week after hemodialysis had been used to overcome erythropoietin resistance in patients with iron deficiency. Theoretically, ascorbic acid scavenges reactive oxygen species and reactive nitrogen species and may thereby prevent oxidative injuries. Investigators reported that administration of high dose ascorbic acid could prevent lipid peroxidation and oxidative DNA damage in patients with ESRD.
In this study, the investigators investigated whether ascorbic acid could decrease venous restenosis after PTA for dysfunctional hemodialysis vascular access.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This was a prospective randomized, single-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Ascorbic acid 300 mg | Active comparator | Drug: Ascorbic Acid 300 MGAscorbic acid 300 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks. |
| Ascorbic acid 600 mg | Active comparator | Drug: Ascorbic Acid 600 MGAscorbic acid 600 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks. |
| Placebo | Placebo comparator | Drug: Normal salineNormal saline was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- clinical signs, i.e., decreased thrill, development of collateral veins, limb swelling, and prolonged bleeding from puncture sites, suggesting vascular access dysfunction
- reduction of flow rate more than 25% from baseline
- total access blood flow rate less than 500 mL/min by ultrasound dilution method
- increased venous pressure during dialysis, as dynamic venous pressure exceeding threshold levels of 150 mmHg in AVF and 160 mmHg in AVG, respectively, under dialysis blood flow 250 ml/min for three consecutive times
Key exclusion criteria (3 listed)
- hospitalized for infection, heart failure, or acute coronary syndrome in recent 3 months
- unable to comply with follow-up visits
- already under ascorbic acid or other antioxidant supplements
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 |
|---|---|---|
| Ascorbic Acid 300 MGAlso: Vitamin CAscorbic acid 300 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks. | Drug | Ascorbic acid 300 mg |
| Ascorbic Acid 600 MGAlso: Vitamin CAscorbic acid 600 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks. | Drug | Ascorbic acid 600 mg |
| Normal salineNormal saline was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks. | Drug | Placebo |
Primary outcome
the extent of restenosis after angioplasty
Time frame: 12 weeks
the extent of restenosis defined by the late loss of minimal vessel diameter and late loss of percentage stenosis at follow-up angiograms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Background: PubMed 8960592Tomoda H, Yoshitake M, Morimoto K, Aoki N. Possible prevention of postangioplasty restenosis by ascorbic acid. Am J Cardiol. 1996 Dec 1;78(11):1284-6. doi: 10.1016/s0002-9149(96)00613-3.
- Derived from this study: PubMed 37916745Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
- Derived from this study: PubMed 31366980Yang CW, Wu CC, Luo CM, Chuang SY, Chen CH, Shen YF, Tarng DC. A randomized feasibility study of the effect of ascorbic acid on post-angioplasty restenosis of hemodialysis vascular access (NCT03524846). Sci Rep. 2019 Jul 31;9(1):11095. doi: 10.1038/s41598-019-47583-w.
- Individual participant dataSharing planned: No
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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.
Chih-Cheng Wu, M.D. study director
Associate professor of Medicine, National Taiwan University, College of Medicine, Taipei, Taiwan
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic Acid 300 MG, Ascorbic Acid 600 MG and Normal saline in people with Hemodialysis Access Failure, run by National Taiwan University Hospital Hsin-Chu Branch.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the extent of restenosis after angioplasty (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524846, which also lists 3 linked publications.
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 15 May 2018.