End Stage Renal DiseaseNCT02827435
Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft
A study testing Rocuronium bromide in people with End Stage Renal Disease and Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Reperfusion of renal graft in kidney transplantation can change the pharmacokinetic-pharmacodynamic (PKPD) parameters of rocuronium. The immediate increase of urine output during surgery may change the PKPD parameters of the drugs, including elimination rate. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- End Stage Renal Disease, Transplantation
- What is being tested?
- Rocuronium bromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2016to 31 Dec 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients scheduled for elective living donor kidney transplantation
- end stage renal disease with oliguria or anuria
- normal BMI (BMI 18.5 ~ 25)
- obtained informed consent
Who cannot join
- patient with underlying neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Eun-Jin Chung, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Chul-Woo Jung, MD. PhD, 82-2-2072-2467, spss@snuh.org
About this study
Official title: Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft During Kidney Transplantation
Reperfusion of renal graft in kidney transplantation can change the pharmacokinetic-pharmacodynamic (PKPD) parameters of rocuronium. The immediate increase of urine output during surgery may change the PKPD parameters of the drugs, including elimination rate. The goal of this study is to characterize the PKPD model of rocuronium during kidney transplantation and establish a basis for adequate dosage of rocuronium in kidney transplantation.
Through PKPD modeling, the changes during reperfusion of the renal graft will be evaluated. Furthermore, the factors related to the changes will be assessed. Adjusting the infusion rate according to the step of kidney transplantation will lead to stable muscle relaxation and fast recovery.
- Conditions
- End Stage Renal Disease, Transplantation
- Being tested
- Rocuronium bromide
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium bromideDrug
Pharmacokinetic-pharmacodynamic modeling blood sampling and Rocuronium bromide concentration measure muscle relaxation evaluation
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium bolus | Experimental | rocuronium bromide 1st bolus 0.1mg/kg, rocuronium bromide 2nd bolus 0.4mg/kg Receives: Drug: Rocuronium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
rocuronium plasma concentration (mcg/ml)
PKPD modeling from measuring plasma rocuronium concentration and excreted urine rocuronium amount
Measured: 0, 1, 3, 5, 10, 30, 60, 90, 120 minutes after rocuronium second bolus injection
acceleromyography data (TOF ratio %)
Muscle relaxation level (TOF, T1) will be evaluated via acceleromyography. The pharmacodynamic modeling with NONMEM throughout the kidney transplantation.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion31 Jul 2019
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul-Woo Jung, Seoul National University Hospital
- Investigators
- Chul-Woo Jung, MD. PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827435
- Sponsor's protocol ID
- Roc_KTPL_PKPD
- Status last verified
- Nov 2023
- First submitted
- 14 Jun 2016
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pharmacokinetic-pharmacodynamic Change of Rocuronium After Reperfusion of Renal Graft During Kidney Transplantation
- ClinicalTrials.gov ID
- NCT02827435
- Acronym / sponsor ID
- Roc_KTPL_PKPD
- Conditions
- End Stage Renal Disease, Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jul 2016 (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.
Reperfusion of renal graft in kidney transplantation can change the pharmacokinetic-pharmacodynamic (PKPD) parameters of rocuronium. The immediate increase of urine output during surgery may change the PKPD parameters of the drugs, including elimination rate. The goal of this study is to characterize the PKPD model of rocuronium during kidney transplantation and establish a basis for adequate dosage of rocuronium in kidney transplantation.
Through PKPD modeling, the changes during reperfusion of the renal graft will be evaluated. Furthermore, the factors related to the changes will be assessed. Adjusting the infusion rate according to the step of kidney transplantation will lead to stable muscle relaxation and fast recovery.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rocuronium bolus | Experimental | Drug: Rocuronium bromiderocuronium bromide 1st bolus 0.1mg/kg, rocuronium bromide 2nd bolus 0.4mg/kg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients scheduled for elective living donor kidney transplantation
- end stage renal disease with oliguria or anuria
- normal BMI (BMI 18.5 ~ 25)
- obtained informed consent
Key exclusion criteria (1 listed)
- patient with underlying neuromuscular disease
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 |
|---|---|---|
| Rocuronium bromidePharmacokinetic-pharmacodynamic modeling blood sampling and Rocuronium bromide concentration measure muscle relaxation evaluation | Drug | Rocuronium bolus |
Primary outcome
rocuronium plasma concentration (mcg/ml)
Time frame: 0, 1, 3, 5, 10, 30, 60, 90, 120 minutes after rocuronium second bolus injection
PKPD modeling from measuring plasma rocuronium concentration and excreted urine rocuronium amount
acceleromyography data (TOF ratio %)
Time frame: intraoperative
Muscle relaxation level (TOF, T1) will be evaluated via acceleromyography. The pharmacodynamic modeling with NONMEM throughout the kidney transplantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- 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.
Eun-Jin Chung, MD contact
Chul-Woo Jung, MD. PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium bromide in people with End Stage Renal Disease and Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
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 1 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 1 Dec 2023. 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 South Korea. 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 Chul-Woo Jung, MD. PhD (82-2-2072-0640, spss@dreamwiz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rocuronium plasma concentration (mcg/ml) (time frame: 0, 1, 3, 5, 10, 30, 60, 90, 120 minutes after rocuronium second bolus injection). 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 1 Dec 2023.