Kidney DiseasesPhase 4FAPCINNCT02444013
Folic Acid for Prevention of Contrast Induced Nephropathy
A Phase 4 study testing Folic acid in people with Kidney Diseases and Urologic Diseases, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to determine whether periprocedural administration of folic acid is effective in the prevention of contrast induced nephropathy in patients undergoing coronary CTA/angiography/angioplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Diseases, Urologic Diseases
- What is being tested?
- Folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- May 2015to May 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inpatients undergoing coronary CTA/angiography/angioplasty
Who cannot join
- exposure to nephrotoxic drugs prior to or during the study period
- end-stage renal failure requiring dialysis
- allergy to iodine-containing contrast medium
- pregnancy
- refusal to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630
Suhua Li, M.D., 86-020-85252168, IMUAWUB@163.com
Jinlai Liu, M.D.
About this study
Official title: Periprocedural Administration of Folic Acid for Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary CTA/Angiography/Angioplasty
The purpose of this study is to determine whether periprocedural administration of folic acid is effective in the prevention of contrast induced nephropathy in patients undergoing coronary CTA/angiography/angioplasty.
Read the detailed description
Hyperhomocysteinemia is considered to be independently associated with a greater risk of contrast induced nephropathy (CIN) in previous studies. However, the relationship between homocysteine-lowering therapy and CIN remains uncertain. Folic acid is considered to be the most common agent for homocysteine-lowering therapy. Therefore, this study aims to determine whether periprocedural administration of folic acid is effective in the prevention of CIN. 400 patients undergoing coronary CTA/angiography/angioplasty are going to be initially enrolled. Of these patients,200 were randomly assigned to receive a standard dose of folic acid (5mg tid, given at least two days before the procedural and continued for two days after), 200 to receive placebo. Blood samples for estimations of serum creatinine were collected at 0, 24 and 48h of contrast agent administration. CIN is defined as an elevation of creatinine by ≥ 25% or ≥ 0.5 mg/dl from baseline within 48h. The occurrence of CIN and the major in-hospital clinical events were recorded and compared between the intervention and control groups.
- Conditions
- Kidney Diseases, Urologic Diseases
- Being tested
- Folic acid, Placebo
- Keywords
- Contrast induced nephropathy
- Medical subject headings
- Kidney Diseases, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acidDrug
Also called Folic uric acid
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Folic acid | Active comparator | Oral folic acid (5 mg, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after. Receives: Drug: Folic acid |
| Placebo | Placebo comparator | Oral placebo (1 tablet, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of contrast-induced nephropathy
Contrast-induced nephropathy is defined as an elevation of serum creatinine of more than 25% or ≥0.5 mg/dl (44 μmol/l) from baseline within 48 hours after contrast exposure
Measured: Within 48 hours after contrast exposure
Secondary outcomes (1)
Major in-hospital clinical events, including death and need for dialysis or hemofiltration
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinlai Liu, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jinlai Liu, M.D., Principal investigator, Organizational Affiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444013
- Sponsor's protocol ID
- SYSU-2015
- Acronym
- FAPCIN
- Status last verified
- May 2015
- First submitted
- 7 Apr 2015
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim SJ, Choi D, Ko YG, Kim JS, Han SH, Kim BK, Kang SW, Hong MK, Jang Y, Choi KH, Yoo TH. Relation of homocysteinemia to contrast-induced nephropathy in patients undergoing percutaneous coronary intervention. Am J Cardiol. 2011 Oct 15;108(8):1086-91. doi: 10.1016/j.amjcard.2011.06.010. Epub 2011 Jul 24.
PubMed 21791335Barbieri L, Verdoia M, Schaffer A, Niccoli G, Perrone-Filardi P, Bellomo G, Marino P, Suryapranata H, Luca GD. Elevated homocysteine and the risk of contrast-induced nephropathy: a cohort study. Angiology. 2015 Apr;66(4):333-8. doi: 10.1177/0003319714533401. Epub 2014 May 15.
PubMed 24830422Li S, Tang X, Peng L, Luo Y, Zhao Y, Chen L, Dong R, Zhu J, Chen Y, Liu J. A head-to-head comparison of homocysteine and cystatin C as pre-procedure predictors for contrast-induced nephropathy in patients undergoing coronary computed tomography angiography. Clin Chim Acta. 2015 Apr 15;444:86-91. doi: 10.1016/j.cca.2015.02.019. Epub 2015 Feb 14.
PubMed 25687162Peng L, Shui X, Tan F, Li Z, Ling Y, Wu B, Chen L, Li S, Peng H. Folic Acid Attenuates Contrast-Induced Nephropathy in Patients With Hyperhomocysteinemia Undergoing Coronary Catheterization: A Randomized Controlled Trial. Front Cardiovasc Med. 2021 Oct 1;8:707328. doi: 10.3389/fcvm.2021.707328. eCollection 2021.
PubMed 34660712
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periprocedural Administration of Folic Acid for Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary CTA/Angiography/Angioplasty
- ClinicalTrials.gov ID
- NCT02444013
- Acronym / sponsor ID
- FAPCIN / SYSU-2015
- Conditions
- Kidney Diseases, Urologic Diseases
- Keywords
- Contrast induced nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 14 May 2015 (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.
The purpose of this study is to determine whether periprocedural administration of folic acid is effective in the prevention of contrast induced nephropathy in patients undergoing coronary CTA/angiography/angioplasty.
Detailed description
Hyperhomocysteinemia is considered to be independently associated with a greater risk of contrast induced nephropathy (CIN) in previous studies. However, the relationship between homocysteine-lowering therapy and CIN remains uncertain. Folic acid is considered to be the most common agent for homocysteine-lowering therapy. Therefore, this study aims to determine whether periprocedural administration of folic acid is effective in the prevention of CIN. 400 patients undergoing coronary CTA/angiography/angioplasty are going to be initially enrolled. Of these patients,200 were randomly assigned to receive a standard dose of folic acid (5mg tid, given at least two days before the procedural and continued for two days after), 200 to receive placebo. Blood samples for estimations of serum creatinine were collected at 0, 24 and 48h of contrast agent administration. CIN is defined as an elevation of creatinine by ≥ 25% or ≥ 0.5 mg/dl from baseline within 48h. The occurrence of CIN and the major in-hospital clinical events were recorded and compared between the intervention and control groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folic acid | Active comparator | Drug: Folic acidOral folic acid (5 mg, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after. |
| Placebo | Placebo comparator | Drug: PlaceboOral placebo (1 tablet, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Inpatients undergoing coronary CTA/angiography/angioplasty
Key exclusion criteria (5 listed)
- exposure to nephrotoxic drugs prior to or during the study period
- end-stage renal failure requiring dialysis
- allergy to iodine-containing contrast medium
- pregnancy
- refusal to give informed consent
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 |
|---|---|---|
| Folic acidAlso: Folic uric acid | Drug | Folic acid |
| Placebo | Drug | Placebo |
Primary outcome
Occurrence of contrast-induced nephropathy
Time frame: Within 48 hours after contrast exposure
Contrast-induced nephropathy is defined as an elevation of serum creatinine of more than 25% or ≥0.5 mg/dl (44 μmol/l) from baseline within 48 hours after contrast exposure
1 secondary outcome
Major in-hospital clinical events, including death and need for dialysis or hemofiltration
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Background: PubMed 21791335Kim SJ, Choi D, Ko YG, Kim JS, Han SH, Kim BK, Kang SW, Hong MK, Jang Y, Choi KH, Yoo TH. Relation of homocysteinemia to contrast-induced nephropathy in patients undergoing percutaneous coronary intervention. Am J Cardiol. 2011 Oct 15;108(8):1086-91. doi: 10.1016/j.amjcard.2011.06.010. Epub 2011 Jul 24.
- Background: PubMed 24830422Barbieri L, Verdoia M, Schaffer A, Niccoli G, Perrone-Filardi P, Bellomo G, Marino P, Suryapranata H, Luca GD. Elevated homocysteine and the risk of contrast-induced nephropathy: a cohort study. Angiology. 2015 Apr;66(4):333-8. doi: 10.1177/0003319714533401. Epub 2014 May 15.
- Background: PubMed 25687162Li S, Tang X, Peng L, Luo Y, Zhao Y, Chen L, Dong R, Zhu J, Chen Y, Liu J. A head-to-head comparison of homocysteine and cystatin C as pre-procedure predictors for contrast-induced nephropathy in patients undergoing coronary computed tomography angiography. Clin Chim Acta. 2015 Apr 15;444:86-91. doi: 10.1016/j.cca.2015.02.019. Epub 2015 Feb 14.
- Derived from this study: PubMed 34660712Peng L, Shui X, Tan F, Li Z, Ling Y, Wu B, Chen L, Li S, Peng H. Folic Acid Attenuates Contrast-Induced Nephropathy in Patients With Hyperhomocysteinemia Undergoing Coronary Catheterization: A Randomized Controlled Trial. Front Cardiovasc Med. 2021 Oct 1;8:707328. doi: 10.3389/fcvm.2021.707328. eCollection 2021.
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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.
Jinlai Liu, M.D. principal investigator
Organizational Affiliation
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 Folic acid in people with Kidney Diseases and Urologic Diseases, run by Third Affiliated Hospital, Sun Yat-Sen University 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 1 inclusion and 5 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 14 May 2015. 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 Suhua Li, M.D. (86-020-85252168, IMUAWUB@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of contrast-induced nephropathy (time frame: Within 48 hours after contrast exposure). 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 NCT02444013, which also lists 4 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 14 May 2015.