Renal ImpairmentPhase 1NCT01613690

Comparing the Pharmacokinetics, Safety and Tolerability of NVA237 in Renal Impairment

A Phase 1 study testing NVA237 in people with Renal Impairment, run by Novartis Pharmaceuticals at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to see how the body processes and gets rid of NVA237 in people who have impaired kidney function compared to people whose kidney function is normal. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: NVA237
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteRussia
Study dates: Jun 2010to Nov 2010
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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female subjects age 18 to 70 years of age inclusive.
Female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through study completion.
Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 17 to 35 kg/m2.
Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent
For renal insufficient subjects only - Subjects must have stable renal disease without evidence of renal progressive disease (for the purpose of this study stable renal disease will be defined as no significant change for 12 weeks).
For health subjects only - A serum creatinine within the normal range and an eGFR >80 mL/min/1.73 m2.
For health subjects only - Matched to at least one renal impaired subjects undergoing study by age (±5 years), sex and weight (±10% BMI).

Who cannot join

Smokers (use of tobacco products in the previous 3 months). Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥ 500 ng/mL. If non-smoking subject are too difficult to recruit, smokers may be allowed to participate in the study provided they commit to smoke no more than 10 cigarettes/day during the days of PK-assessment
For healthy subjects, use of any prescription drugs, herbal and fitness/bodybuilding/athletic performance-enhancing supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing
Recent (within the last three [3] years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting (unless related to water withdrawal during dialysis), palpitations, etc).
Recent (within the last three [3] years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.
Total WBC count which falls outside the range of 3000-12,000/μL, or platelets <100,000/μl at screening.
History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Novartis Investigative Site
Moscow

Other trials in Russia

About this study

Official title: An Open Label, Non-randomized, Parallel-group Study to Characterize and Compare the Pharmacokinetics, Safety, and Tolerability of a Single Dose of NVA237 in Subjects With Mild, Moderate, Severe and End-stage Renal Impairment With That in Matched Healthy Control Subjects

The purpose of this study is to see how the body processes and gets rid of NVA237 in people who have impaired kidney function compared to people whose kidney function is normal.

Conditions: Renal Impairment
Being tested: NVA237
Keywords: Renal impairment, NVA237, Pharmacokinetics
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NVA237Drug
NVA237 is administered via a BREEZHALER device

Study groups in NCT01613690
Study group	Role	What they receive
Healthy volunteers	Experimental	control group receiving 100 μg NVA237 Receives: Drug: NVA237
Mild renal impairment	Experimental	(eGFR 50-80 mL/min/1.73m2) receiving 100 μg NVA237 Receives: Drug: NVA237
Moderate renal impairment	Experimental	(eGFR 30-49 mL/min/1.73m2) receiving 100 μg NVA237 Receives: Drug: NVA237
Severe renal impairment	Experimental	(eGFR <30 mL/min1.73m2) receiving 100 μg NVA237 Receives: Drug: NVA237
End-stage subjects requiring dialysis (ESRD)	Experimental	receiving 100 μg NVA237 Receives: Drug: NVA237

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentration of NVA2105 using PK parameter of primary interest - area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Measured: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of primary interest - maximum plasma concentration (Cmax)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Measured: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of primary interest - renal clearance (CLR)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Measured: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of secondary interest - time to Cmax (Tmax)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Measured: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of secondary interest - AUC extrapolated to infinity (AUCinf)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Measured: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of secondary interest - terminal elimination half-life, determined from plasma concentrations and urinary excretion rates (T1/2)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Measured: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter of secondary interest - apparent systemic clearance (CL/F)
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Measured: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter - amount excreted into the urine from time 0 to 96 h post-dose (Ae0-96h)
Samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Urine, Analyte: NVA237
Measured: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter - T1/2
Samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Urine, Analyte: NVA237
Measured: Day 1, 2, 3, 4 and 5
Concentration of NVA2105 using PK parameter - CLR
Samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Urine, Analyte: NVA237
Measured: Day 1, 2, 3, 4 and 5

Secondary outcomes (3)

Change in effect of dialysis in End-stage subjects requiring dialysis (ESRD) using PK parameter Cmax
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Measured: Day 1 of each treatment period
Change in effect of dialysis in End-stage subjects requiring dialysis using PK parameter AUClast
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Measured: Day 1 of each treatment period
Safety and tolerability of a single inhalation dose of 100μg NVA237 in subjects with mild, moderate, severe, and end-stage renal impairment
Adverse events will be based on evaluation of physical signs, electrocardiograms and clinical laboratory assessments
Measured: Reviewed during each study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Nov 2010

First posted7 Jun 2012 (estimated)
Study startJun 2010
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal ImpairmentStudies 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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01613690
Sponsor's protocol ID: CNVA237A2105
Status last verified: Jun 2012
First submitted: 5 Jun 2012
Last updated: 19 Dec 2020
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
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

All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Non-randomized, Parallel-group Study to Characterize and Compare the Pharmacokinetics, Safety, and Tolerability of a Single Dose of NVA237 in Subjects With Mild, Moderate, Severe and End-stage Renal Impairment With That in Matched Healthy Control Subjects
ClinicalTrials.gov ID: NCT01613690
Acronym / sponsor ID: CNVA237A2105
Conditions: Renal Impairment
Keywords: Renal impairment, NVA237, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 7 Jun 2012 (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.

The purpose of this study is to see how the body processes and gets rid of NVA237 in people who have impaired kidney function compared to people whose kidney function is normal.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Healthy volunteers	Experimental	Drug: NVA237control group receiving 100 μg NVA237
Mild renal impairment	Experimental	Drug: NVA237(eGFR 50-80 mL/min/1.73m2) receiving 100 μg NVA237
Moderate renal impairment	Experimental	Drug: NVA237(eGFR 30-49 mL/min/1.73m2) receiving 100 μg NVA237
Severe renal impairment	Experimental	Drug: NVA237(eGFR <30 mL/min1.73m2) receiving 100 μg NVA237
End-stage subjects requiring dialysis (ESRD)	Experimental	Drug: NVA237receiving 100 μg NVA237

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male and female subjects age 18 to 70 years of age inclusive.
Female subjects of childbearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the study, through study completion.
Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 17 to 35 kg/m2.
Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent
For renal insufficient subjects only - Subjects must have stable renal disease without evidence of renal progressive disease (for the purpose of this study stable renal disease will be defined as no significant change for 12 weeks).

Key exclusion criteria (8 listed)

Smokers (use of tobacco products in the previous 3 months). Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥ 500 ng/mL. If non-smoking subject are too difficult to recruit, smokers may be allowed to participate in the study provided they commit to smoke no more than 10 cigarettes/day during the days of PK-assessment
For healthy subjects, use of any prescription drugs, herbal and fitness/bodybuilding/athletic performance-enhancing supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing
Recent (within the last three [3] years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting (unless related to water withdrawal during dialysis), palpitations, etc).
Recent (within the last three [3] years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.

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
NVA237NVA237 is administered via a BREEZHALER device	Drug	End-stage subjects requiring dialysis (ESRD), Healthy volunteers, Mild renal impairment, Moderate renal impairment, Severe renal impairment

Primary outcome

Concentration of NVA2105 using PK parameter of primary interest - area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1, 2, 3, 4 and 5
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Concentration of NVA2105 using PK parameter of primary interest - maximum plasma concentration (Cmax)
Time frame: Day 1, 2, 3, 4 and 5
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Concentration of NVA2105 using PK parameter of primary interest - renal clearance (CLR)
Time frame: Day 1, 2, 3, 4 and 5
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Concentration of NVA2105 using PK parameter of secondary interest - time to Cmax (Tmax)
Time frame: Day 1, 2, 3, 4 and 5
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Concentration of NVA2105 using PK parameter of secondary interest - AUC extrapolated to infinity (AUCinf)
Time frame: Day 1, 2, 3, 4 and 5
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Concentration of NVA2105 using PK parameter of secondary interest - terminal elimination half-life, determined from plasma concentrations and urinary excretion rates (T1/2)
Time frame: Day 1, 2, 3, 4 and 5
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Concentration of NVA2105 using PK parameter of secondary interest - apparent systemic clearance (CL/F)
Time frame: Day 1, 2, 3, 4 and 5
Blood samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Plasma, Analyte: NVA237
Concentration of NVA2105 using PK parameter - amount excreted into the urine from time 0 to 96 h post-dose (Ae0-96h)
Time frame: Day 1, 2, 3, 4 and 5
Samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Urine, Analyte: NVA237
Concentration of NVA2105 using PK parameter - T1/2
Time frame: Day 1, 2, 3, 4 and 5
Samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Urine, Analyte: NVA237
Concentration of NVA2105 using PK parameter - CLR
Time frame: Day 1, 2, 3, 4 and 5
Samples will be collected at various time points on each visit day; Compound: NVA237 100ug, Matrix: Urine, Analyte: NVA237

3 secondary outcomes

Change in effect of dialysis in End-stage subjects requiring dialysis (ESRD) using PK parameter Cmax
Time frame: Day 1 of each treatment period
Change in effect of dialysis in End-stage subjects requiring dialysis using PK parameter AUClast
Time frame: Day 1 of each treatment period
Safety and tolerability of a single inhalation dose of 100μg NVA237 in subjects with mild, moderate, severe, and end-stage renal impairment
Time frame: Reviewed during each study visit

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 19 Dec 2020.
Results for CNVA237A2105 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.

Related trials for Renal Impairment

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
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
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

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NVA237 in people with Renal Impairment, run by Novartis Pharmaceuticals at 1 site in Russia.

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 8 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 19 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 1 site in Russia. 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?

Concentration of NVA2105 using PK parameter of primary interest - area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast) (time frame: Day 1, 2, 3, 4 and 5). The study lists 10 primary outcomes in all. 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 NCT01613690.

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 19 Dec 2020.