Nephrotic SyndromePhase 4NCT03347357
Pharmacokinetics of Tacrolimus in Children
A Phase 4 study testing Tacrolimus in people with Nephrotic Syndrome, run by Shandong University.
Trial summary
the present study was conducted to assess the population pharmacokinetics of tacrolimus in children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen of tacrolimus for use in these patients. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 30 Sep 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients have been diagnosed with nephrotic syndrome;
- age range: 1 month to 18 years old
- tacrolimus used as part of regular treatment
Who cannot join
- expected survival time less than the treatment cycle;
- patients with other factors that researcher considers unsuitable for inclusion.
About this study
Official title: Population Pharmacokinetics of Tacrolimus in Children With Nephrotic Syndrome
the present study was conducted to assess the population pharmacokinetics of tacrolimus in children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen of tacrolimus for use in these patients.
- Conditions
- Nephrotic Syndrome
- Being tested
- Tacrolimus
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Tacrolimus was administered orally at a dose of 0.05 mg/kg/dose twice daily (bid) for children with nephrotic syndrome.
| Study group | Role | What they receive |
|---|---|---|
| tacrolimus | Experimental | Not described Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of plasma concentration of Tacrolimus
To detect the plasma concentrations of Tacrolimus after oral administration
Measured: at 1,2,3,6,9,12 hours after oral administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Jan 2012
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
- Investigators
- Wei Zhao, Ph.D, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347357
- Sponsor's protocol ID
- 2017TAC002
- Status last verified
- Oct 2017
- First submitted
- 30 Oct 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Tacrolimus in Children With Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT03347357
- Acronym / sponsor ID
- 2017TAC002
- Conditions
- Nephrotic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 20 Nov 2017 (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.
the present study was conducted to assess the population pharmacokinetics of tacrolimus in children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen of tacrolimus for use in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tacrolimus | Experimental | Drug: Tacrolimus |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients have been diagnosed with nephrotic syndrome;
- age range: 1 month to 18 years old
- tacrolimus used as part of regular treatment
Key exclusion criteria (2 listed)
- expected survival time less than the treatment cycle;
- patients with other factors that researcher considers unsuitable for inclusion.
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 |
|---|---|---|
| TacrolimusTacrolimus was administered orally at a dose of 0.05 mg/kg/dose twice daily (bid) for children with nephrotic syndrome. | Drug | tacrolimus |
Primary outcome
change of plasma concentration of Tacrolimus
Time frame: at 1,2,3,6,9,12 hours after oral administration
To detect the plasma concentrations of Tacrolimus after oral administration
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 20 Nov 2017.
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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.
Wei Zhao, Ph.D principal investigator
Shandong University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus in people with Nephrotic Syndrome, run by Shandong University.
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 3 inclusion and 2 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 20 Nov 2017. 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. 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 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?
change of plasma concentration of Tacrolimus (time frame: at 1,2,3,6,9,12 hours after oral administration). 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 20 Nov 2017.