Renal InsufficiencyPhase 1NCT03087942
Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects
A Phase 1 study testing QAW039, QAW39A and QAW39A2107 in people with Renal Insufficiency, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
The aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient population. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- QAW039, QAW39A and QAW39A2107
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Jul 2017to 7 Aug 2018
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects must satisfy the criteria for normal renal function as evidenced by normal Glomerular Filtration Rate (GFR): eGFR ≥ 90 mL/min/1.73m2; each healthy subject must match in age (+/- 10years), gender, smoking status, and weight (+/- 15%), a patient from the renail impaired patient groups:
- A body mass index (BMI) within the range of 18 - 36 kg/m2
- ESRD patients on hemodialysis: an glomerulo filtration rat GFR of < 15 mL/min/1.73 m2
- patients with severe renal impairment: GFR of< 30 mL/min/1.73m2 (without need of hemodialysis);
- patients with moderate renal impairment: 30 mL/min/1.73m2 ≤ eGFR < 60 mL/min/1.73m2;
- patients with mild impairment: 60 mL/min/1.73m2 ≤ eGFR < 90 mL/min/1.73m2
Who cannot join
- Pregnant or nursing (lactating) women
- History or evidence of any inherited bilirubin disease or disorder
- subjects participating in another study
- malignancies in the past
- Hemoglobin levels below 10 g/dL at screening
- HIV positiv
Show all 10Show fewer
- Heavy smokers (≥20 cigarettes per day)
- Liver disease, as indicated by ALT, γ-GT, AST and alkaline phosphatase which should not exceed twice the upper limit of normal and should be stable (e.g. increased liver values known from previous patient records). Serum bilirubin > 27 μmol/L (1.6 mg/dL)
- Clinically significant ECG changes and/or arrhythmias
- Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open-label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics of Fevipiprant (QAW039) in Patients With End-stage Renal Disease on Hemodialysis and Optionally in Patients With Severe to Moderate and Mild Renal Impairment Compared to Matched Healthy Volunteers Including a Cross-over Assessment in End-stage Renal Disease Patients on the Effect of Dialysis on Fevipiprant Pharmacokinetics
The aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient population.
The study also aims to determine the effect of dialysis on the fevipiprant pharmacokinetic profile as the procedure might remove a significant fraction of the drug.
Read the detailed description
The purpose of this study is to determine if the pharmacokinetic profile of fevipiprant is different in patients with renal impariment compared to healthy matched volunteers to an extent that would require an adjustment of the dosage. Data from this study will be used to guide enrollment criteria in future clinical trials and to support regulatory submission and labeling information
- Conditions
- Renal Insufficiency
- Being tested
- QAW039, QAW39A, QAW39A2107
- Keywords
- end stage renal disase ESRD, dialysis effect on pharmacokinetics PK, renal impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAW039Drug
Also called fevipiprant
450 mg
QAW39ADrug
Also called fevipiprant
450 mg
QAW39A2107Drug
Also called fevipiprant
450 mg
QAW39A2107Drug
Also called fevipiprant
450 mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ESRD patients Receives: Drug: QAW039 |
| Group 2 | Experimental | healthy volunteers Receives: Drug: QAW39A |
| Group 3 | Experimental | severe and moderate renal impaired patients Receives: Drug: QAW39A2107 |
| Group 4 | Experimental | mild renal impaired patients Receives: Drug: QAW39A2107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Plasma concentration of fevipiprant by AUClast
AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Measured: 68 hours post dose
Pharmacokinetics: Plasma concentration of fevipiprant by AUCinf
AUCinf is the area under the plasma concentration-time curve from time zero to infinity
Measured: 68 hours post dose
Pharmacokinetics: Plasma concentration of fevipiprant by Cmax
Cmax is the observed maximum plasma concentration following drug administration
Measured: 68 hours post dose
Pharmacokinetics: Plasma contentration of fevipiprant by AUC0-68h
AUC0-68h is the area under the plasma concentration from time zero to time 68 hours of the last measured concentration above the limit of quantification after dosing
Measured: 68 hours post dose
Secondary outcomes (8)
Relationship between plasma pharmacokinetics of fevipiprant by AUClast and between eGFR as well as creatinine clearance
AUClast (the area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration ) related to eGFR estimated by the Modification of Diet in Renal Disease (MDRD) formula, and Cockcroft-Gault (C-G) estimated creatinine clearance
Measured: 68 hours post dose
Relationship between plasma pharmacokinetics of fevipiprant by AUCinf and between eGFR as well as creatinine clearance
AUCinf (the area under the plasma concentration time curve from time zero to infinity) related to eGFR estimated by the Modification of Diet in Renal Disease (MDRD) formula, and Cockcroft-Gault (C-G) estimated creatinine clearance
Measured: 68 hours post dose
Relationship between plasma pharmacokinetics of fevipiprant by Cmax and between eGFR as well as creatinine clearance
Cmax (observed maximum plasma concentration following drug administration) related to eGFR estimated by the Modification of Diet in Renal Disease (MDRD) formula, and Cockcroft-Gault (C-G) estimated creatinine clearance
Measured: 68 hours post dose
Pharmacokinetics of the metabolite CCN362 by AUClast
AUClast is the area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration
Measured: 68 hours post dose
Pharmacokinetics of the metabolite CCN362 by AUCinf
AUCinf is the area under the plasma concentration time curve from time zero to infinity
Measured: 68 hours post dose
Pharmacokinetics of the metabolite CCN362 by Cmax
Cmax is the observed maximum plasma concentration following drug administration
Measured: 68 hours post dose
Pharmacokinetics: plasma concentration of fevipiprant in patients with End Stage Renal Disease (ESRD)
Partial AUCs (AUCt1-t2) covering the time interval of dialysis, Cmax and total AUCs (AUC0-68h and/or AUCinf) will be compared
Measured: 68 hours post dose
urinary excretion of fevipiprant and metabolite in patients with renal impairment compared to healthy controls
Renal clearance (CLr) and fraction of dose excreted in urine for fevipiprant and metabolite
Measured: 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start5 Jul 2017
- Primary completion7 Aug 2018
- Study completion7 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087942
- Sponsor's protocol ID
- CQAW039A2107
- Other IDs
- 2016-004218-81, 2016
- Status last verified
- Jun 2020
- First submitted
- 17 Mar 2017
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics of Fevipiprant (QAW039) in Patients With End-stage Renal Disease on Hemodialysis and Optionally in Patients With Severe to Moderate and Mild Renal Impairment Compared to Matched Healthy Volunteers Including a Cross-over Assessment in End-stage Renal Disease Patients on the Effect of Dialysis on Fevipiprant Pharmacokinetics
- ClinicalTrials.gov ID
- NCT03087942
- Acronym / sponsor ID
- CQAW039A2107
- Conditions
- Renal Insufficiency
- Keywords
- end stage renal disase ESRD, dialysis effect on pharmacokinetics PK, renal impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 23 Mar 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 aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient population.
The study also aims to determine the effect of dialysis on the fevipiprant pharmacokinetic profile as the procedure might remove a significant fraction of the drug.
Detailed description
The purpose of this study is to determine if the pharmacokinetic profile of fevipiprant is different in patients with renal impariment compared to healthy matched volunteers to an extent that would require an adjustment of the dosage. Data from this study will be used to guide enrollment criteria in future clinical trials and to support regulatory submission and labeling information
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: QAW039ESRD patients |
| Group 2 | Experimental | Drug: QAW39Ahealthy volunteers |
| Group 3 | Experimental | Drug: QAW39A2107severe and moderate renal impaired patients |
| Group 4 | Experimental | Drug: QAW39A2107mild renal impaired patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy subjects must satisfy the criteria for normal renal function as evidenced by normal Glomerular Filtration Rate (GFR): eGFR ≥ 90 mL/min/1.73m2; each healthy subject must match in age (+/- 10years), gender, smoking status, and weight (+/- 15%), a patient from the renail impaired patient groups:
- A body mass index (BMI) within the range of 18 - 36 kg/m2
- ESRD patients on hemodialysis: an glomerulo filtration rat GFR of < 15 mL/min/1.73 m2
- patients with severe renal impairment: GFR of< 30 mL/min/1.73m2 (without need of hemodialysis);
- patients with moderate renal impairment: 30 mL/min/1.73m2 ≤ eGFR < 60 mL/min/1.73m2;
Key exclusion criteria (10 listed)
- Pregnant or nursing (lactating) women
- History or evidence of any inherited bilirubin disease or disorder
- subjects participating in another study
- malignancies in the past
- Hemoglobin levels below 10 g/dL at screening
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 |
|---|---|---|
| QAW039Also: fevipiprant450 mg | Drug | Group 1 |
| QAW39AAlso: fevipiprant450 mg | Drug | Group 2 |
| QAW39A2107Also: fevipiprant450 mg | Drug | Group 3 |
| QAW39A2107Also: fevipiprant450 mg | Drug | Group 4 |
Primary outcome
Pharmacokinetics: Plasma concentration of fevipiprant by AUClast
Time frame: 68 hours post dose
AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
Pharmacokinetics: Plasma concentration of fevipiprant by AUCinf
Time frame: 68 hours post dose
AUCinf is the area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics: Plasma concentration of fevipiprant by Cmax
Time frame: 68 hours post dose
Cmax is the observed maximum plasma concentration following drug administration
Pharmacokinetics: Plasma contentration of fevipiprant by AUC0-68h
Time frame: 68 hours post dose
AUC0-68h is the area under the plasma concentration from time zero to time 68 hours of the last measured concentration above the limit of quantification after dosing
8 secondary outcomes
Relationship between plasma pharmacokinetics of fevipiprant by AUClast and between eGFR as well as creatinine clearance
Time frame: 68 hours post dose
Relationship between plasma pharmacokinetics of fevipiprant by AUCinf and between eGFR as well as creatinine clearance
Time frame: 68 hours post dose
Relationship between plasma pharmacokinetics of fevipiprant by Cmax and between eGFR as well as creatinine clearance
Time frame: 68 hours post dose
Pharmacokinetics of the metabolite CCN362 by AUClast
Time frame: 68 hours post dose
Pharmacokinetics of the metabolite CCN362 by AUCinf
Time frame: 68 hours post dose
Pharmacokinetics of the metabolite CCN362 by Cmax
Time frame: 68 hours post dose
Pharmacokinetics: plasma concentration of fevipiprant in patients with End Stage Renal Disease (ESRD)
Time frame: 68 hours post dose
urinary excretion of fevipiprant and metabolite in patients with renal impairment compared to healthy controls
Time frame: 24 hours post dose
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 11 Dec 2020.
- Results for CQAW039A2107 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QAW039, QAW39A and QAW39A2107 in people with Renal Insufficiency, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
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 6 inclusion and 10 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 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetics: Plasma concentration of fevipiprant by AUClast (time frame: 68 hours post dose). The study lists 4 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 11 Dec 2020.