Renal ImpairmentPhase 1NCT01459250
Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects
A Phase 1 study testing AGO178C in people with Renal Impairment, run by Novartis Pharmaceuticals at 4 sites in United States.
Trial summary
This study will assess the pharmacokinetics, safety and tolerability of a single dose of AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease with that in healthy matched control subjects. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- AGO178C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2011to Aug 2011
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mild, moderate, severe renally impaired or ESRD patients.
- Healthy male or female subjects to match renally impaired patients in BMI (±15%), age (± 7 years) and gender (in this order). Smoking status (yes or no) will also be used as a final criterion, if deemed feasible by the Investigator.
Who cannot join
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study as defined in the protocol.
- Smokers, smoking 10 cigarettes or more per day from screening to study completion
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study
- Co-medication for healthy subjects
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Novartis Investigative Site
Knoxville, Tennessee, 37920
Novartis Investigative Site
Miami, Florida, 33136
Novartis Investigative Site
Minneapolis, Minnesota, 55404
Novartis Investigative Site
Orlando, Florida, 32809-3017
About this study
Official title: An Open Label, Non-randomised, Parallel Group Study to Characterise and Compare the Pharmacokinetics, Safety and Tolerability of a Single Dose of AGO178C in Subjects With Mild, Moderate, Severe Renal Impairment and End-stage Renal Disease With That in Healthy Matched Control Subjects
This study will assess the pharmacokinetics, safety and tolerability of a single dose of AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease with that in healthy matched control subjects.
- Conditions
- Renal Impairment
- Being tested
- AGO178C
- Keywords
- AGO178C,, renal impairment,, ESRD,, pharmacokinetics
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGO178CDrug
| Study group | Role | What they receive |
|---|---|---|
| AGO178C | Experimental | Not described Receives: Drug: AGO178C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Composite of AGO178C pharmacokinetics in blood and urine samples.
Measured: pre dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h and 36 h post dose
Secondary outcomes (1)
Measure: Safety and tolerability of AGO178C as assessed by adverse events reports, vital signs, ECGs and safety laboratory tests.
Measured: Up to 9 Days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011
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
- Single group
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT01459250
- Sponsor's protocol ID
- CAGO178C2104
- Status last verified
- Oct 2011
- First submitted
- 23 Sep 2011
- Last updated
- 8 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non-randomised, Parallel Group Study to Characterise and Compare the Pharmacokinetics, Safety and Tolerability of a Single Dose of AGO178C in Subjects With Mild, Moderate, Severe Renal Impairment and End-stage Renal Disease With That in Healthy Matched Control Subjects
- ClinicalTrials.gov ID
- NCT01459250
- Acronym / sponsor ID
- CAGO178C2104
- Conditions
- Renal Impairment
- Keywords
- AGO178C,, renal impairment,, ESRD,, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- First posted
- 25 Oct 2011 (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.
This study will assess the pharmacokinetics, safety and tolerability of a single dose of AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease with that in healthy matched control subjects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AGO178C | Experimental | Drug: AGO178C |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild, moderate, severe renally impaired or ESRD patients.
- Healthy male or female subjects to match renally impaired patients in BMI (±15%), age (± 7 years) and gender (in this order). Smoking status (yes or no) will also be used as a final criterion, if deemed feasible by the Investigator.
Key exclusion criteria (6 listed)
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study as defined in the protocol.
- Smokers, smoking 10 cigarettes or more per day from screening to study completion
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study
- Co-medication for healthy subjects
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 |
|---|---|---|
| AGO178C | Drug | AGO178C |
Primary outcome
Measure: Composite of AGO178C pharmacokinetics in blood and urine samples.
Time frame: pre dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h and 36 h post dose
1 secondary outcome
Measure: Safety and tolerability of AGO178C as assessed by adverse events reports, vital signs, ECGs and safety laboratory tests.
Time frame: Up to 9 Days 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 8 Dec 2020.
- Results for CAGO178C2104 can be found on the Novartis Clinical Trial Results WebsiteLink 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGO178C in people with Renal Impairment, run by Novartis Pharmaceuticals at 4 sites in United States.
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 2 inclusion and 6 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 8 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 4 sites in United States. 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?
Measure: Composite of AGO178C pharmacokinetics in blood and urine samples. (time frame: pre dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h and 36 h post dose). 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 8 Dec 2020.