Surveillance Protocol BiopsyNCT02294097
Protocol-Specified Modification of Immunosuppression Directed to Protocol Biopsy in Kidney Transplantation
A study testing Surveillance protocol kidney allograft biopsy in people with Surveillance Protocol Biopsy, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The risk-benefit of surveillance-protocol biopsy (SPBx) in kidney transplantation remains unclear. The study aims to compare outcomes of recipients with SPBx approach to recipients with standard approach which allograft biopsy was performed only when indicated. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Surveillance Protocol Biopsy
- What is being tested?
- Surveillance protocol kidney allograft biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2014to Dec 2016
- Phase
- Interventional
- 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All kidney transplant recipients underwent transplantation at Chulalongkorn University
Who cannot join
- Pregnancy
- Recipients who cannot withhold aspirin, clopidogrel, warfarin, etc.
- Non-cooperated recipients
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, 10330
Wiwat Chancharoenthana, MD, MSc, wiwatmd@hotmail.com
About this study
Official title: The Outcomes of Protocol-Specified Modification of Immunosuppression Directed to Histological Diagnosis by Surveillance Protocol Biopsy
The risk-benefit of surveillance-protocol biopsy (SPBx) in kidney transplantation remains unclear. The study aims to compare outcomes of recipients with SPBx approach to recipients with standard approach which allograft biopsy was performed only when indicated.
Read the detailed description
The present randomized-controlled trial in kidney transplant patients aims to compare the outcomes and complications between who underwent immunosuppessive drug modification under surveillance-protocol biopsy and who underwent immunosuppressive drug modification following tough level only.
- Conditions
- Surveillance Protocol Biopsy
- Being tested
- Surveillance protocol kidney allograft biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveillance protocol kidney allograft biopsyProcedure or surgery
Surveillance protocol biopsy under ultrasound-guided will perform at post-operative day 7, month 3, month 6, month 12, and month 24
| Study group | Role | What they receive |
|---|---|---|
| Non-biopsy | No intervention | Population in this arm will be adjusted immunosuppressive drug only from the result of tough level. |
| Protocol biopsy | Experimental | Population in this arm will be adjusted immunosuppressive drug upon both pathological findings and the result of tough level. Receives: Procedure: Surveillance protocol kidney allograft biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
24 h-CrCl
Measured: 24 months
Secondary outcomes (2)
Renal pathology
interstitial fibrosis, rejection, calcineurin inhibitor toxicity
Measured: 24 months
Complications
hematoma, arteriovenous fistula
Measured: immediate, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surveillance Protocol BiopsyStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wiwat Chancharoenthana, Chulalongkorn University
- Investigators
- Wiwat Chancharoenthana, MD.,MSc., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294097
- Sponsor's protocol ID
- WWC-005
- Status last verified
- Nov 2014
- First submitted
- 15 Nov 2014
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of Protocol-Specified Modification of Immunosuppression Directed to Histological Diagnosis by Surveillance Protocol Biopsy
- ClinicalTrials.gov ID
- NCT02294097
- Acronym / sponsor ID
- WWC-005
- Conditions
- Surveillance Protocol Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Nov 2014 (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 risk-benefit of surveillance-protocol biopsy (SPBx) in kidney transplantation remains unclear. The study aims to compare outcomes of recipients with SPBx approach to recipients with standard approach which allograft biopsy was performed only when indicated.
Detailed description
The present randomized-controlled trial in kidney transplant patients aims to compare the outcomes and complications between who underwent immunosuppessive drug modification under surveillance-protocol biopsy and who underwent immunosuppressive drug modification following tough level only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-biopsy | No intervention | –Population in this arm will be adjusted immunosuppressive drug only from the result of tough level. |
| Protocol biopsy | Experimental | Procedure: Surveillance protocol kidney allograft biopsyPopulation in this arm will be adjusted immunosuppressive drug upon both pathological findings and the result of tough level. |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All kidney transplant recipients underwent transplantation at Chulalongkorn University
Key exclusion criteria (3 listed)
- Pregnancy
- Recipients who cannot withhold aspirin, clopidogrel, warfarin, etc.
- Non-cooperated recipients
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 |
|---|---|---|
| Surveillance protocol kidney allograft biopsySurveillance protocol biopsy under ultrasound-guided will perform at post-operative day 7, month 3, month 6, month 12, and month 24 | Procedure or surgery | Protocol biopsy |
Primary outcome
Renal function
Time frame: 24 months
24 h-CrCl
2 secondary outcomes
Renal pathology
Time frame: 24 months
Complications
Time frame: immediate, 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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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.
Wiwat Chancharoenthana, MD.,MSc. principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveillance protocol kidney allograft biopsy in people with Surveillance Protocol Biopsy, run by Chulalongkorn University at 1 site in Thailand.
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 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: status not confirmed, as of the sponsor's last update on 19 Nov 2014. 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 Thailand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Wiwat Chancharoenthana, MD., MSc. (+66 22564251 ext. 101, wiwatmd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function (time frame: 24 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 Nov 2014.