Renal InsufficiencyPhase 1NCT02172339
The Pharmacokinetic, Safety and Tolerability of Tiotropium in Outpatients With Renal Impairment in Comparison to Healthy Subjects
A Phase 1 study testing Tiotropium, solution ampoules in people with Renal Insufficiency, run by Boehringer Ingelheim.
Trial summary
Study to investigate pharmacokinetics of a single i.v. dose of tiotropium (4.8 mcg) in patients with renal impairment in comparison to healthy subjects. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Tiotropium, solution ampoules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Dec 1998
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects:
- Subject with normal renal function ( creatinine clearance of 80% of predicted creatinine clearance in healthy volunteers), as confirmed by normal physical examination including vital signs, ECG and laboratory values
- Calculated creatinine clearance (male);
- = ((140 - age(yr)) x (Wt (kg))) / (72 x predicted serum creatinine (mg/dL))
- Calculated creatinine clearance (female);
- = ((140 - age(yr)) x (Wt(kg))) / (85 x predicted serum creatinine (mg/dL))
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- Subject with impaired renal function must be of age related good health and without clinically significant abnormalities as assessed during the physical examination. Mildly impaired renal patients were defined as those with creatinine clearance of 40 - 80% of predicted creatinine clearance; moderately impaired renal patients were defined as those with creatinine clearance of 10 - 40% of predicted creatinine clearance. Laboratory values of subjects with renal impairment could have been outside the normal range if the deviations were due to the underlying renal disease.
- Male or female, age between 40 and 70 years with normal body - weight index (+/- 25%, Broca-index)
- Subjects with normal 12 - lead ECG recording
- Subjects with normal physical examination
- Subjects with normal clinical and laboratory tests (except for indicators of renal impairment)
- Female of child bearing potential must have a negative pregnancy test
- All subjects must have a negative HIV-Ab test and negative Hepatitis B test
- All subjects must have a negative drug screening
- All subjects must sign a written informed consent prior to enrollment
Who cannot join
- Subjects with a history of more then moderate alcohol consumption (more than 1 litre of beer per day or the equivalent amount of alcohol in any other alcoholic beverage, approximately 50 g of alcohol per day). 24 hours before dosing and 24 hours post dosing, alcohol was not permitted
- Present or past participation in a drug detoxification program
- Smokers
- Subjects requiring any concomitant medication not compatible with this study
- Subjects with hypotension (systolic blood pressure less than 100 mmHg, diastolic less than 60 mmHg) or hypertension (systolic blood pressure more than 165 mmHg or diastolic more than 100 mmHg) under adequate medication
- Subjects who participated in a clinical trial of any other investigational drug within two months prior to the start of this study
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- Pregnant or lactating women or women of child bearing potential not using a medically approved means contraception. (i.e., oral contraceptives, intrauterine devices, diaphragm)
- Subjects who donated blood within three months prior to the start of the study
- Subjects with a history of chronic or recurrent convulsive disorders or ongoing hepatic dysfunction
- Subjects with ongoing acute systemic illness or recovery from acute systemic illness
- Subjects with a history of cancer within the last five years
- Subjects with known hypersensitivity to anticholinergic drugs
- Subjects with known symptomatic prostatic hypertrophy or bladder neck obstruction
- Subjects with known narrow-angle glaucoma
About this study
Official title: The Pharmacokinetic, Safety and Tolerability of Tiotropium (4.8 mcg, Single i.v. Dose) in Outpatients With Renal Impairment in Comparison to Healthy Subjects (Open Label, Group Comparison, Two-center Study)
Study to investigate pharmacokinetics of a single i.v. dose of tiotropium (4.8 mcg) in patients with renal impairment in comparison to healthy subjects.
- Conditions
- Renal Insufficiency
- Being tested
- Tiotropium, solution ampoules
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium, solution ampoulesDrug
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium | Experimental | group comparison (healthy, renal impairment) Receives: Drug: Tiotropium, solution ampoules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC (0-4h) of plasma levels of tiotropium after dosing)
Measured: pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration
Renal clearance of tiotropium (CLren )
Measured: Day 1, 2, 3, 7, 11, 15, 18, 22 and 25 (0-4h, 4-8h), additionally -4 -0 h on day 1
Terminal half-life of tiotropium
Measured: pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration
Urinary excretion (0-4h) of tiotropium, Ae 0-4h
Measured: Day 1, 2, 3, 7, 11, 15, 18, 22 and 25 (0-4h, 4-8h), additionally -4 -0 h on day 1
Secondary outcomes (8)
Change from baseline in Pulse Rate (PR)
Measured: baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25
Change from baseline in Blood pressure (BP)
Measured: baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25
Number of Participants with Serious and Non-Serious Adverse Events
Measured: up to day 25
Change from baseline in electrocardiogram (ECG)
Measured: baseline, day 1, 2, 7, 15 and 25
Maximum measured concentration of the analyte in plasma (Cmax )
Measured: pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Measured: pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration
Change in FEV1 (Forced expiratory volume in one second)
Measured: baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25
Change in FVC (Forced vital capacity)
Measured: baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startApr 1998
- Primary completionDec 1998
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 Boehringer IngelheimThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172339
- Sponsor's protocol ID
- 205.134
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetic, Safety and Tolerability of Tiotropium (4.8 mcg, Single i.v. Dose) in Outpatients With Renal Impairment in Comparison to Healthy Subjects (Open Label, Group Comparison, Two-center Study)
- ClinicalTrials.gov ID
- NCT02172339
- Acronym / sponsor ID
- 205.134
- Conditions
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Dec 1998 (actual)
- First posted
- 24 Jun 2014 (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.
Study to investigate pharmacokinetics of a single i.v. dose of tiotropium (4.8 mcg) in patients with renal impairment in comparison to healthy subjects.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tiotropium | Experimental | Drug: Tiotropium, solution ampoulesgroup comparison (healthy, renal impairment) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects:
- Calculated creatinine clearance (male);
- = ((140 - age(yr)) x (Wt (kg))) / (72 x predicted serum creatinine (mg/dL))
- Calculated creatinine clearance (female);
- = ((140 - age(yr)) x (Wt(kg))) / (85 x predicted serum creatinine (mg/dL))
Key exclusion criteria (14 listed)
- Subjects with a history of more then moderate alcohol consumption (more than 1 litre of beer per day or the equivalent amount of alcohol in any other alcoholic beverage, approximately 50 g of alcohol per day). 24 hours before dosing and 24 hours post dosing, alcohol was not permitted
- Present or past participation in a drug detoxification program
- Smokers
- Subjects requiring any concomitant medication not compatible with this study
- Subjects with hypotension (systolic blood pressure less than 100 mmHg, diastolic less than 60 mmHg) or hypertension (systolic blood pressure more than 165 mmHg or diastolic more than 100 mmHg) under adequate medication
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 |
|---|---|---|
| Tiotropium, solution ampoules | Drug | Tiotropium |
Primary outcome
Area under the curve (AUC (0-4h) of plasma levels of tiotropium after dosing)
Time frame: pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration
Renal clearance of tiotropium (CLren )
Time frame: Day 1, 2, 3, 7, 11, 15, 18, 22 and 25 (0-4h, 4-8h), additionally -4 -0 h on day 1
Terminal half-life of tiotropium
Time frame: pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration
Urinary excretion (0-4h) of tiotropium, Ae 0-4h
Time frame: Day 1, 2, 3, 7, 11, 15, 18, 22 and 25 (0-4h, 4-8h), additionally -4 -0 h on day 1
8 secondary outcomes
Change from baseline in Pulse Rate (PR)
Time frame: baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25
Change from baseline in Blood pressure (BP)
Time frame: baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: up to day 25
Change from baseline in electrocardiogram (ECG)
Time frame: baseline, day 1, 2, 7, 15 and 25
Maximum measured concentration of the analyte in plasma (Cmax )
Time frame: pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration
Change in FEV1 (Forced expiratory volume in one second)
Time frame: baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25
Change in FVC (Forced vital capacity)
Time frame: baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25
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 24 Jun 2014.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tiotropium, solution ampoules in people with Renal Insufficiency, run by Boehringer Ingelheim.
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 15 inclusion and 14 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 24 Jun 2014. 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 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?
Area under the curve (AUC (0-4h) of plasma levels of tiotropium after dosing) (time frame: pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration). 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 24 Jun 2014.