Nephrotic SyndromePISTONSNCT04045171
Population Pharmacokinetics of Tacrolimus in Nephrotic Syndrome
An observational study of Nephrotic Syndrome and Tacrolimus, run by The Third Xiangya Hospital of Central South University.
Trial summary
This study will use a multi-center, prospective design, with a "Real World Study" model, to include 200 patients with nephrotic syndrome. based on the Population Pharmacokinetics (PPK) model, it will study genotype and clinical factors in patients with nephrotic syndrome, to explore the Pharmacokinetics/… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nephrotic Syndrome, Tacrolimus, Pharmacokinetics
- What is being tested?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2019to 31 Dec 2020
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Nephrotic Syndrome are suit for use of Tacrolimus.
Who may be able to join
- （1）Patients with Nephrotic Syndrome：
- Proteinuria greater than 3.5 g/24 hour
- Serum albumin <30 g/l
- Clinical evidence of peripheral oedema
- Hyperlipidemia 1) and 2) are necessary for diagnosis.
- （2）18-75years old（include 75），gender is not limited；
- （3）Voluntary signing informed consent。
Who cannot join
- （1）Secondary nephrotic syndrome；
- （2）Allergic to Tacrolimus or other unsuitable use of Tacrolimus；
- （3）With other immunosuppressive agents such as cyclosporin A, cyclophosphamide, mycophenolate mofetil, leflunomide, tripterygium wilfordii (hormone is not restricted)；
- （4）Severe liver dysfunction (transaminase > 3 ULN, or bilirubin > 3 ULN)；
- （5）Severe renal insufficiency（eGFR<30 ml/min/1.73m2）
- （6）Joined other clinical trials within 1 month；
Show all 9Show fewer
- （7）Missing clinical data；
- （8）Pregnancy, lactation or planning for pregnancy within 12 months；
- （9）Researchers believe that patients who are not suitable for this clinical trial。
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Population Pharmacokinetics of Tacrolimus for Optimal Dose in Patients With Nephrotic Syndrome
This study will use a multi-center, prospective design, with a "Real World Study" model, to include 200 patients with nephrotic syndrome. based on the Population Pharmacokinetics (PPK) model, it will study genotype and clinical factors in patients with nephrotic syndrome, to explore the Pharmacokinetics/ Pharmacodynamics (PK/PD) relationship of Tacrolimus in patients with nephrotic syndrome, and develop an optimal medication regimen.
- Conditions
- Nephrotic Syndrome, Tacrolimus, Pharmacokinetics
- Being tested
- Tacrolimus
- Keywords
- Nephrotic Syndrome, Tacrolimus, Population Pharmacokinetics
- 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, oral, 0.05-0.075 mg/kg/d, Q12h, 6～12 months
What is being measured
The primary outcome is the main question the study is designed to answer.
change of plasma concentration of Tacrolimus
Study the plasma concentration of Tacrolimus in patients with nephrotic syndrome
Measured: at 0hour，2hours，4hours，6hours，9hours，12hours after oral administration
Secondary outcomes (1)
Genotypes as measured by next generation sequencing
Genotypes as measured by next generation sequencing
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start10 Aug 2019 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Provincial People's Hospital, ZhuZhou Central Hospital, First People's Hospital of Chenzhou
- Responsible party
- Sponsor
- Investigators
- ZHIJUN HUANG, Dr., Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045171
- Sponsor's protocol ID
- XY3-IIT-TAC1905A01
- Acronym
- PISTONS
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We welcomes researchers interested in collaboration. We request a short research proposal including information on the background, research questions and methods, timetable and budget, and authorship. For more information please contact the principal investigator.
Publications
Lu T, Zhu X, Xu S, Zhao M, Huang X, Wang Z, Zhao L. Dosage Optimization Based on Population Pharmacokinetic Analysis of Tacrolimus in Chinese Patients with Nephrotic Syndrome. Pharm Res. 2019 Feb 4;36(3):45. doi: 10.1007/s11095-019-2579-6.
PubMed 30719576Hao GX, Huang X, Zhang DF, Zheng Y, Shi HY, Li Y, Jacqz-Aigrain E, Zhao W. Population pharmacokinetics of tacrolimus in children with nephrotic syndrome. Br J Clin Pharmacol. 2018 Aug;84(8):1748-1756. doi: 10.1111/bcp.13605. Epub 2018 May 22.
PubMed 29637588Radhakrishnan J, Cattran DC. The KDIGO practice guideline on glomerulonephritis: reading between the (guide)lines--application to the individual patient. Kidney Int. 2012 Oct;82(8):840-56. doi: 10.1038/ki.2012.280. Epub 2012 Aug 15.
PubMed 22895519
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Tacrolimus for Optimal Dose in Patients With Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT04045171
- Acronym / sponsor ID
- PISTONS / XY3-IIT-TAC1905A01
- Conditions
- Nephrotic Syndrome, Tacrolimus, Pharmacokinetics
- Keywords
- Nephrotic Syndrome, Tacrolimus, Population Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Hunan Provincial People's Hospital, ZhuZhou Central Hospital, First People's Hospital of Chenzhou
- Study start
- 10 Aug 2019 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Aug 2019 (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.
This study will use a multi-center, prospective design, with a "Real World Study" model, to include 200 patients with nephrotic syndrome. based on the Population Pharmacokinetics (PPK) model, it will study genotype and clinical factors in patients with nephrotic syndrome, to explore the Pharmacokinetics/ Pharmacodynamics (PK/PD) relationship of Tacrolimus in patients with nephrotic syndrome, and develop an optimal medication regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Nephrotic Syndrome are suit for use of Tacrolimus.
Key inclusion criteria (7 listed)
- （1）Patients with Nephrotic Syndrome：
- （2）18-75years old（include 75），gender is not limited；
- （3）Voluntary signing informed consent。
Key exclusion criteria (9 listed)
- （1）Secondary nephrotic syndrome；
- （2）Allergic to Tacrolimus or other unsuitable use of Tacrolimus；
- （3）With other immunosuppressive agents such as cyclosporin A, cyclophosphamide, mycophenolate mofetil, leflunomide, tripterygium wilfordii (hormone is not restricted)；
- （4）Severe liver dysfunction (transaminase > 3 ULN, or bilirubin > 3 ULN)；
- （5）Severe renal insufficiency（eGFR<30 ml/min/1.73m2）
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, oral, 0.05-0.075 mg/kg/d, Q12h, 6～12 months | Drug | – |
Primary outcome
change of plasma concentration of Tacrolimus
Time frame: at 0hour，2hours，4hours，6hours，9hours，12hours after oral administration
Study the plasma concentration of Tacrolimus in patients with nephrotic syndrome
1 secondary outcome
Genotypes as measured by next generation sequencing
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Background: PubMed 30719576Lu T, Zhu X, Xu S, Zhao M, Huang X, Wang Z, Zhao L. Dosage Optimization Based on Population Pharmacokinetic Analysis of Tacrolimus in Chinese Patients with Nephrotic Syndrome. Pharm Res. 2019 Feb 4;36(3):45. doi: 10.1007/s11095-019-2579-6.
- Background: PubMed 29637588Hao GX, Huang X, Zhang DF, Zheng Y, Shi HY, Li Y, Jacqz-Aigrain E, Zhao W. Population pharmacokinetics of tacrolimus in children with nephrotic syndrome. Br J Clin Pharmacol. 2018 Aug;84(8):1748-1756. doi: 10.1111/bcp.13605. Epub 2018 May 22.
- Background: PubMed 22895519Radhakrishnan J, Cattran DC. The KDIGO practice guideline on glomerulonephritis: reading between the (guide)lines--application to the individual patient. Kidney Int. 2012 Oct;82(8):840-56. doi: 10.1038/ki.2012.280. Epub 2012 Aug 15.
- Individual participant dataSharing planned: No. We welcomes researchers interested in collaboration. We request a short research proposal including information on the background, research questions and methods, timetable and budget, and authorship. For more information please contact the principal investigator.
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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.
ZHIJUN HUANG, Dr. principal investigator
The Third Xiangya Hospital of Central South University
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotic Syndrome and Tacrolimus, run by The Third Xiangya Hospital of Central South 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 7 inclusion and 9 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 5 Aug 2019. 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.
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 ZHIJUN HUANG, Dr. (073188618339, huangzj@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of plasma concentration of Tacrolimus (time frame: at 0hour，2hours，4hours，6hours，9hours，12hours after oral administration). 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 NCT04045171, which also lists 3 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 5 Aug 2019.