Kidney TransplantationPhase 4NCT00570856
Trial of Folic Acid Effect on Hcy and cIMT After Kidney Tx
A Phase 4 study testing Folic acid in people with Kidney Transplantation, run by Shahid Beheshti University of Medical Sciences.
Trial summary
To see the effect of Folic acid supplementation after kidney transplantation on plasma total homocysteine level and carotid intimal-media thickness Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Kidney Transplantation
- 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
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Mar 2006
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having hyperhomocysteinemia(tHcy>12.5 µmol/L in men and 11.5 µmol/L in women )
- No evident history of CVD 4. no evidence of cigarette smoking
- not participating in other clinical studies on evaluation of cardiac diseases and
- not taking any lipid lowering treatment
- not being pregnant or breast feeding a baby(women)
- Having HIV or viral hepatitis infections.
Who cannot join
- unstable condition of the transplanted kidney (Cr> 3 mg/dl, BUN > 50 mg/dl)
- Cyclosporine (CsA) intoxication
- New onset of any severe disease ( such as MI, stroke, DM, etc.).
About this study
Official title: Clinical Trial of Effectiveness of Folic Acid Therapy on Homocysteine Level and Carotid Intima-Media Thickness After Kidney Transplantation
To see the effect of Folic acid supplementation after kidney transplantation on plasma total homocysteine level and carotid intimal-media thickness
- Conditions
- Kidney Transplantation
- Being tested
- Folic acid, Placebo
- Keywords
- Folic Acid, Homocysteine, intima-media thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acidDrug
Folic acid 5 mg/day
PlaceboDrug
Placebo similar to the folic acid tablets, 1/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Folic acid supplementation Receives: Drug: Folic acid |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma level of total homocysteine (tHcy)
Measured: 6 months
Secondary outcomes (1)
carotid intima-media thickness (cIMT)
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 posted11 Dec 2007 (estimated)
- Study startJun 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mohsen Nafar, MD- Nephrologist, Study chair, Urology Nephrology Research Center, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, IranFarideh Khatami, Master of Science, Principal investigator, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, IranBabak Kardavani, M.D., Principal investigator, Urology Nephrology Research Center, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570856
- Sponsor's protocol ID
- 110
- Other IDs
- 110
- Status last verified
- Dec 2007
- First submitted
- 10 Dec 2007
- Last updated
- 19 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Effectiveness of Folic Acid Therapy on Homocysteine Level and Carotid Intima-Media Thickness After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00570856
- Acronym / sponsor ID
- 110
- Conditions
- Kidney Transplantation
- Keywords
- Folic Acid, Homocysteine, intima-media thickness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Mar 2006 (actual)
- First posted
- 11 Dec 2007 (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.
To see the effect of Folic acid supplementation after kidney transplantation on plasma total homocysteine level and carotid intimal-media thickness
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Folic acidFolic acid supplementation |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- having hyperhomocysteinemia(tHcy>12.5 µmol/L in men and 11.5 µmol/L in women )
- No evident history of CVD 4. no evidence of cigarette smoking
- not participating in other clinical studies on evaluation of cardiac diseases and
- not taking any lipid lowering treatment
- not being pregnant or breast feeding a baby(women)
Key exclusion criteria (3 listed)
- unstable condition of the transplanted kidney (Cr> 3 mg/dl, BUN > 50 mg/dl)
- Cyclosporine (CsA) intoxication
- New onset of any severe disease ( such as MI, stroke, DM, etc.).
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 acidFolic acid 5 mg/day | Drug | 1 |
| PlaceboPlacebo similar to the folic acid tablets, 1/day | Drug | 2 |
Primary outcome
plasma level of total homocysteine (tHcy)
Time frame: 6 months
1 secondary outcome
carotid intima-media thickness (cIMT)
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2007.
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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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.
Mohsen Nafar, MD- Nephrologist study chair
Urology Nephrology Research Center, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
Farideh Khatami, Master of Science principal investigator
Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
Babak Kardavani, M.D. principal investigator
Urology Nephrology Research Center, Labbafi Nejad Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Folic acid in people with Kidney Transplantation, run by Shahid Beheshti University of Medical Sciences.
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 6 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: stopped early, as of the sponsor's last update on 19 Dec 2007. 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 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?
The study was stopped early. Results are not available in the source record.
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?
plasma level of total homocysteine (tHcy) (time frame: 6 months). 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 19 Dec 2007.