Renal InsufficiencyPhase 1NCT02320045
Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects
A Phase 1 study testing ITCA 650 (Exenatide in osmotic mini pump) in people with Renal Insufficiency, run by Intarcia Therapeutics at 4 sites in 2 countries.
Trial summary
A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and moderate renal impairment compared to the pharmacokinetics of subjects with normal renal function Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- ITCA 650 (Exenatide in osmotic mini pump)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2014to Jul 2015
- 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index between 22 and 40 kg/m²
- Subjects meeting pre-defined estimated glomerular filtration rate criteria and creatinine clearance rate
- Normal (≥90 mL/min/1.73 m2)
- Mild (60-89 mL/min/1.73 m2)
- Moderate (45-59 mL/min/1.73 m2)
- Moderate (>30-44 mL/min/1.73 m2)
Who cannot join
- History of acute metabolic complications
- Uncontrolled Hypertension
- History of Hypersensitivity to Exenatide
- Cardiovascular Disease
- History of Acute or chronic pancreatitis
- Personal or family history of Multiple endocrine neoplasia type 2
- History of Medullary thyroid cancer
- Severe renal failure, End stage renal disease or dialysis
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States1 site
Intarcia Therapeutics Inc.
Boston, Massachusetts, 02210
About this study
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics of ITCA 650 in Subjects With Mild and Moderate Renal Impairment Compared to the Pharmacokinetics of Subjects With Normal Renal Function
A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and moderate renal impairment compared to the pharmacokinetics of subjects with normal renal function
- Conditions
- Renal Insufficiency
- Being tested
- ITCA 650 (Exenatide in osmotic mini pump)
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITCA 650 (Exenatide in osmotic mini pump)Drug
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Normal | Experimental | Normal Subjects estimated creatinine clearance (eGFR) ≥90 mL/min/1.73 m2 Receives: Drug: ITCA 650 (Exenatide in osmotic mini pump) |
| Group 2: Mild Renal Dysfunction | Experimental | Subjects with Mild Renal Dysfunction estimated creatinine clearance (eGFR) 60-89 mL/min/1.73 m2 Receives: Drug: ITCA 650 (Exenatide in osmotic mini pump) |
| Goup 3: Moderate Renal Dysfunction | Experimental | Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) 45-59 mL/min/1.73 m2 Receives: Drug: ITCA 650 (Exenatide in osmotic mini pump) |
| Group 4: Moderate Renal Dysfunction | Experimental | Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) >30-44 mL/min/1.73 m2 Receives: Drug: ITCA 650 (Exenatide in osmotic mini pump) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-h Area under the Curve at steady state (AUCt,ss)
Measured: Approximately 67 Days
Secondary outcomes (6)
Rate of adverse events
Measured: Approximately 67 Days
Severity of adverse events
Measured: Approximately 67 Days
Safety laboratory parameters
Measured: Approximately 67 Days
Vital signs
Measured: Approximately 67 Days
Electrocardiogram
Measured: Approximately 67 Days
Physical exam
Measured: Approximately 67 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intarcia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320045
- Sponsor's protocol ID
- ITCA 650 CLP-109
- Status last verified
- Jun 2016
- First submitted
- 26 Nov 2014
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Pharmacokinetics of ITCA 650 in Subjects With Mild and Moderate Renal Impairment Compared to the Pharmacokinetics of Subjects With Normal Renal Function
- ClinicalTrials.gov ID
- NCT02320045
- Acronym / sponsor ID
- ITCA 650 CLP-109
- Conditions
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 19 Dec 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.
A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and moderate renal impairment compared to the pharmacokinetics of subjects with normal renal function
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Normal | Experimental | Drug: ITCA 650 (Exenatide in osmotic mini pump)Normal Subjects estimated creatinine clearance (eGFR) ≥90 mL/min/1.73 m2 |
| Group 2: Mild Renal Dysfunction | Experimental | Drug: ITCA 650 (Exenatide in osmotic mini pump)Subjects with Mild Renal Dysfunction estimated creatinine clearance (eGFR) 60-89 mL/min/1.73 m2 |
| Goup 3: Moderate Renal Dysfunction | Experimental | Drug: ITCA 650 (Exenatide in osmotic mini pump)Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) 45-59 mL/min/1.73 m2 |
| Group 4: Moderate Renal Dysfunction | Experimental | Drug: ITCA 650 (Exenatide in osmotic mini pump)Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) >30-44 mL/min/1.73 m2 |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index between 22 and 40 kg/m²
- Subjects meeting pre-defined estimated glomerular filtration rate criteria and creatinine clearance rate
Key exclusion criteria (8 listed)
- History of acute metabolic complications
- Uncontrolled Hypertension
- History of Hypersensitivity to Exenatide
- Cardiovascular Disease
- History of Acute or chronic pancreatitis
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 |
|---|---|---|
| ITCA 650 (Exenatide in osmotic mini pump) | Drug | Goup 3: Moderate Renal Dysfunction, Group 1: Normal, Group 2: Mild Renal Dysfunction, Group 4: Moderate Renal Dysfunction |
Primary outcome
24-h Area under the Curve at steady state (AUCt,ss)
Time frame: Approximately 67 Days
6 secondary outcomes
Rate of adverse events
Time frame: Approximately 67 Days
Severity of adverse events
Time frame: Approximately 67 Days
Safety laboratory parameters
Time frame: Approximately 67 Days
Vital signs
Time frame: Approximately 67 Days
Electrocardiogram
Time frame: Approximately 67 Days
Physical exam
Time frame: Approximately 67 Days
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 3 Jun 2016.
Related trials for Renal Insufficiency
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
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
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)
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.
4 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 ITCA 650 (Exenatide in osmotic mini pump) in people with Renal Insufficiency, run by Intarcia Therapeutics at 4 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 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 3 Jun 2016. 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 Germany, 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?
24-h Area under the Curve at steady state (AUCt,ss) (time frame: Approximately 67 Days). 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 3 Jun 2016.