Chronic Kidney DiseasePhase 4NCT05747768
A Clinical Study to Evaluate the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Healthy Volunteers and Renal Impairment Patients
A Phase 4 study testing Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin in people with Chronic Kidney Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
1. To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Chinese people with renal impairment; 2. To explore the effect of dialysis on the functional changes of P-gp, CYP3A4, OATP1B and BCRP in patients with end-stage renal disease; 3. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2022to 31 Dec 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants:
- male or female , Chinese (individuals have Chinese descent) subjects, Age between 18-65 (include) with the ability of cognizance;
- body mass index (BMI) of 18.5 to 24 kg/m2 for all participants ; body weight for male >50 kg; a total body weight for female >45 kg;
- female must be non-pregnant, non-breast feeding and if she is reproductive potential: must agree to use (and/have their partner use) effective methods of birth control beginning at screening ,throughout the study and until 6 months after last dosing of study drug;
- is a non-smoker or moderate smoker (≤20 cigarettes/day or the equivalent);
- signed the Inform Consent Form , fully understood the trial conduction and comply with the requirement of the research;
Show all 16Show fewer
- Participants with mild to moderate , moderate to severe , severe renal impairment or end stage renal disease:
- has a clinical diagnosis of renal impairment and meets the protocol-specified renal impairment function qualifications at screening;
- with the classification of KDIGO (Kidney Disease Improving Global Outcomes ), the mild to moderate renal impairment patients have eGFR between 45 to 90(include) mL/min/1.73m2 based on MDRD (Modification of Diet in Renal Disease Study) equation, without dialysis before;
- with the classification of KDIGO (Kidney Disease Improving Global Outcomes ), the moderate to severe renal impairment patients have eGFR between 30 to 44(include) mL/min/1.73m2 based on MDRD(Modification of Diet in Renal Disease Study) equation, without dialysis before;
- with the classification of KDIGO (Kidney Disease Improving Global Outcomes ), The moderate to severe renal impairment patients have eGFR between 15 to 29(include) mL/min/1.73m2 based on MDRD(Modification of Diet in Renal Disease Study) equation, without dialysis before;
- with the classification of KDIGO (Kidney Disease Improving Global Outcomes ), The end stage renal disease patients have eGFR below 15 (include) mL/min/1.73m2 based on MDRD(Modification of Diet in Renal Disease Study) equation, with dialysis therapy;
- participants with mild to moderate , moderate to severe , severe renal impairment or end stage renal disease: With stable renal function lasted for three months before first oral dose ; the shrinkage of eGFR be within 30%;
- Healthy participants ,besides:
- has baseline eGFR ≥ 90 mL/min based on MDRD (Modification of Diet in Renal Disease Study) equation;
- is judged to be in good health based on medical history, physical examination, vital signs and laboratory safety tests, without clinically significant laboratory abnormalities.
Who cannot join
- is mentally or legally incapacitated at the time of the screening visit or expected during the conduct of the study;
- history of stroke, chronic seizures, or major neurological disorders;
- history of malignant neoplastic disease;
- history or presence of alcoholism or drug abuse within the past 6 months;
- history of hypersensitive reaction or allergic to study drug (including midazolam, dabigatran Etexilate, pitavastatin, atorvastatin, rosuvastatin), only if with researchers permission;
- blood donation within the past 4 weeks or lost more than 500 mL blood before screening;
Show all 19Show fewer
- apheresis within the past 8 weeks before screening;
- take weak/moderate inhibiters or inducers of CYP3A/BCRP/OATP1B/P-gp within 14 days before screening, including but not limited to: clarithromycin, boceprevir, cobicistatdanoprevir, grapefruit juice, indinavir, ketoconazole, telaprevir, paritaprevir, Telithromycin, troleandomycin, voriconazole, nafazodone, Idelalisib, nelfinavir, fluconazole, aprepitant, ciprofloxacin, conivaptan , crizotinib, cyclosporin A, diltiazem, fluvoxamine, imatinib, tofisopam, atazanavir, erythromycingemfibrozilsimepreviramiodarone, carvedilol, itraconazole, lapatinib, lopinavir, ritonavir, propafenone, quinidine, ranolazine, saquinavir, telaprevir, verapamil, tipranavir, curcumin, Eltrombopag, phenytoin, rifampicin, apalutamide, carbamazepine, St. John's Wort, mitotan, enzalutamide, bosentan, efavirenz, primidone, phenobarbital;
- intolerance of venous blood collection;
- history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary abnormalities or diseases, include cancer, traumatic brain injury, persistent viral infection, rheumatoid arthritis, inflammatory bowel disease, NAFLD, Liver cirrhosis, HIV, Hyperthyreosis, Cushing syndrome, Parkinson or has a history of Parkinson in his family;
- history of myocardial infarction, cerebral stroke, cerebral infarction within 3 months;
- history of gastrointestinal diseases: irritable bowel syndrome, enteric bacterial overgrowth syndrome, gastroesophageal reflux disease, Gallstones, coeliac disease, Crohn disease, Ulcerative Colitis, active peptic ulcers;
- subjects who test positive at screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HbsAg), and syphilis;
- Participants with mild to moderate, moderate to severe, severe renal impairment or end stage renal disease,exclusion criteria are appended below:
- history of renal transplant or nephrectomy;
- presence of uncontrolled type 2 diabetes mellitus (T2DM), a history of type 1 diabetes or ketoacidosis;
- participants with rapid fluctuation of renal function according to previous laboratory examination; or have been diagnosed of renal stenosis. The definition of rapid fluctuation of renal function refers to the fluctuation of eGFR greater than 30% within 3 months after the examination. If no historical measurements are available, two examinations will be used to demonstrate stability: fluctuation of eGFR less than 30% between two consecutive examinations within 3 months before screening;
- Healthy participants ,exclusion criteria are appended below:
- 1.presence of hypoglycemia, glucose intolerance,uncontrolled type 2 diabetes mellitus (T2DM) or ketoacidosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Dongyang Liu, liudongyang@vip.sina.com
Dongyang Liu
About this study
- To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Chinese people with renal impairment;
- To explore the effect of dialysis on the functional changes of P-gp, CYP3A4, OATP1B and BCRP in patients with end-stage renal disease;
- Validation of urotoxic molecules as possible biomarkers that can assess intestinal P-gp function.
- Conditions
- Chronic Kidney Disease
- Being tested
- Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatinDrug
Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin were provided by the Department of Pharmacy, Peking University Third Hospital, and were dissolved and mixed with normal saline respectively, and the mixing process needed to be fully stirred. Then, according to the concentration of the drug mixed solution, the corresponding volume of mixed solution was given to achieve the dosage of 10 μg midazolam, 375 μg dabigatran etexilate, 10 μg pitavastatin, 50 μg rosuvastatin and 100 μg atorvastatin. In order to avoid the food effect, the test drugs were administered on an empty stomach on the administration day in this experiment.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Healthy volunteer received drug combinations（10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin） on an empty stomach Receives: Drug: Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin |
| Patients with mild-to-moderate renal impairment | Experimental | Patients with mild-to-moderate renal impairment received drug combinations（10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin） on an empty stomach Receives: Drug: Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin |
| Patients with moderate to severe renal impairment | Experimental | Patients with moderate to severe renal impairment received drug combinations（10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin） on an empty stomach Receives: Drug: Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin |
| Patients with severe renal impairment | Experimental | Patients with severe renal impairment received drug combinations（10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin） on an empty stomach Receives: Drug: Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin |
| Patients with end-stage renal disease | Experimental | Patients with end-stage renal disease received drug combinations（10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin） on an empty stomach Receives: Drug: Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentration
Measured: Baseline and within 24 hours after administration
dialysate concentration
Measured: 1 day
Secondary outcomes (2)
biomarker concentration
Measured: Baseline and within 24 hours after administration
urine concentration
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start15 Jul 2022
- Primary completion1 Jun 2024 (estimated)
- 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 Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongyang Liu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747768
- Sponsor's protocol ID
- DCTC-IIR202229
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Healthy Volunteers and Renal Impairment Patients
- ClinicalTrials.gov ID
- NCT05747768
- Acronym / sponsor ID
- DCTC-IIR202229
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Feb 2023 (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.
- To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Chinese people with renal impairment;
- To explore the effect of dialysis on the functional changes of P-gp, CYP3A4, OATP1B and BCRP in patients with end-stage renal disease;
- Validation of urotoxic molecules as possible biomarkers that can assess intestinal P-gp function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatinHealthy volunteer received drug combinations（10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin） on an empty stomach |
| Patients with mild-to-moderate renal impairment | Experimental | Drug: Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatinPatients with mild-to-moderate renal impairment received drug combinations（10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin） on an empty stomach |
| Patients with moderate to severe renal impairment | Experimental | Drug: Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatinPatients with moderate to severe renal impairment received drug combinations（10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin） on an empty stomach |
| Patients with severe renal impairment | Experimental | Drug: Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatinPatients with severe renal impairment received drug combinations（10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin） on an empty stomach |
| Patients with end-stage renal disease | Experimental | Drug: Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatinPatients with end-stage renal disease received drug combinations（10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin） on an empty stomach |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- male or female , Chinese (individuals have Chinese descent) subjects, Age between 18-65 (include) with the ability of cognizance;
- body mass index (BMI) of 18.5 to 24 kg/m2 for all participants ; body weight for male >50 kg; a total body weight for female >45 kg;
- female must be non-pregnant, non-breast feeding and if she is reproductive potential: must agree to use (and/have their partner use) effective methods of birth control beginning at screening ,throughout the study and until 6 months after last dosing of study drug;
- is a non-smoker or moderate smoker (≤20 cigarettes/day or the equivalent);
- signed the Inform Consent Form , fully understood the trial conduction and comply with the requirement of the research;
Key exclusion criteria (19 listed)
- is mentally or legally incapacitated at the time of the screening visit or expected during the conduct of the study;
- history of stroke, chronic seizures, or major neurological disorders;
- history of malignant neoplastic disease;
- history or presence of alcoholism or drug abuse within the past 6 months;
- history of hypersensitive reaction or allergic to study drug (including midazolam, dabigatran Etexilate, pitavastatin, atorvastatin, rosuvastatin), only if with researchers permission;
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 |
|---|---|---|
| Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatinMidazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin were provided by the Department of Pharmacy, Peking University Third Hospital, and were dissolved and mixed with normal saline respectively, and the mixing process needed to be fully stirred. Then, according to the concentration of the drug mixed solution, the corresponding volume of mixed solution was given to achieve the dosage of 10 μg midazolam, 375 μg dabigatran etexilate, 10 μg pitavastatin, 50 μg rosuvastatin and 100 μg atorvastatin. In order to avoid the food effect, the test drugs were administered on an empty stomach on the administration day in this experiment. | Drug | Healthy Volunteers, Patients with end-stage renal disease, Patients with mild-to-moderate renal impairment, Patients with moderate to severe renal impairment, Patients with severe renal impairment |
Primary outcome
plasma concentration
Time frame: Baseline and within 24 hours after administration
dialysate concentration
Time frame: 1 day
2 secondary outcomes
biomarker concentration
Time frame: Baseline and within 24 hours after administration
urine concentration
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam, dabigatran etexilate, pitavastatin, rosuvastatin and atorvastatin in people with Chronic Kidney Disease, run by Peking University Third Hospital at 1 site in China.
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 16 inclusion and 19 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 28 Feb 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 China. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongyang Liu ((86)010-82266658, liudongyang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma concentration (time frame: Baseline and within 24 hours after administration). 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 28 Feb 2023.