Renal InsufficiencyPhase 1NCT03235375
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects
A Phase 1 study testing MEDI0382 in people with Renal Insufficiency, run by MedImmune LLC at 4 sites in 2 countries.
Trial summary
A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- MEDI0382
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 27 Oct 2017to 24 Apr 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must provide written informed consent
- BMI greater than or equal to 17 and less than or equal to 40 kg/m2
- Creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 mL/min)
- Females of childbearing potential must use a highly effective form of contraception.
Who cannot join
- Any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety.
- Subjects on dialysis
- Subjects with pancreatitis
- Renal transplant subjects
- Females pregnant or lactating
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
New Zealand2 sites
Research Site
Auckland, 1010
Research Site
Christchurch, 8011
About this study
Official title: A Phase 1, Open-Label, Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of MEDI0382 in Subjects With Renal Impairment
A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.
Read the detailed description
This is an open-label, single-dose, parallel group study to evaluate the PK, safety, tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4 groups based on renal function.
- Conditions
- Renal Insufficiency
- Being tested
- MEDI0382
- Keywords
- Kidney Failure, Kidney Insufficiency, Renal Failure, Renal Insufficiency, MEDI0382
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI0382Drug
MEDI0382 administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Group 1: End Stage Renal Disease (ESRD) | Experimental | Subjects with CrCl <20ml/min will receive MEDI0382 administered subcutaneously Receives: Drug: MEDI0382 |
| Group 2: Severe and ESRD Subjects | Experimental | Subjects with CrCl >20 and < 30 ml/min will receive MEDI0382 administered subcutaneously Receives: Drug: MEDI0382 |
| Group 3: Healthy Subjects | Active comparator | Subjects with CrCl >90 ml/min will receive MEDI0382 administered subcutaneously Receives: Drug: MEDI0382 |
| Group 4: Moderate Renal Disease | Experimental | Subjects with CrCl > or equal to 30 and < 60 mL/min will receive MEDI0382 administered subcutaneously Receives: Drug: MEDI0382 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration of MEDI0382 (Cmax)
The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data
Measured: 0-48 hours
Area under the Concentration Time Curve (AUC) of MEDI0382
The area under the plasma concentration-time curve to 48 hours concentration determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations
Measured: 0-48 hours
Secondary outcomes (8)
Time to maximum observed concentration (Tmax)
Time to maximum observed concentration.
Measured: 0-48 hours
apparent clearance (Cl/F)
The apparent clearance will be calculated as CL/F=Dose/AUC(0-inf)
Measured: 0-48 hours
AUCinf
The AUC extrapolated to infinity will be calculated, where data permit, as the sum of AUC((0-t) and Ct/z, where Ct is the observed plasma concentration obtained from the log-linear regression analysis of the last quantifiable time-point and z is the terminal phase rate constant.
Measured: 0-48 hours
Half-life (T1/2)
The apparent terminal elimination half-life (t1/2) obtained as the ratio of ln2/z, where z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data
Measured: 0-48 hours
Anti-drug Antibody (ADA) titer
ADA titer through to day 28
Measured: Day -1 to day 28
Number of subjects with Adverse Events
Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Measured: Study onset till 28 days post dosing
Number of subjects with Adverse Events
Vital Signs (systolic and diastolic blood pressure, pulse rate, temperature and respiratory rates)
Measured: Study onset till 28 days post dosing
Number of subjects with Adverse Events
Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)
Measured: Study onset till 28 days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start27 Oct 2017
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235375
- Sponsor's protocol ID
- D5670C00008
- Status last verified
- Apr 2018
- First submitted
- 27 Jul 2017
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klein G, Petrone M, Yang Y, Hoang T, Hazlett S, Hansen L, Flor A. Pharmacokinetics and Safety of Cotadutide, a GLP-1 and Glucagon Receptor Dual Agonist, in Individuals with Renal Impairment: A Single-Dose, Phase I, Bridging Study. Clin Pharmacokinet. 2023 Jun;62(6):881-890. doi: 10.1007/s40262-023-01239-1. Epub 2023 May 4.
PubMed 37140727
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of MEDI0382 in Subjects With Renal Impairment
- ClinicalTrials.gov ID
- NCT03235375
- Acronym / sponsor ID
- D5670C00008
- Conditions
- Renal Insufficiency
- Keywords
- Kidney Failure, Kidney Insufficiency, Renal Failure, Renal Insufficiency, MEDI0382
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 1 Aug 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.
A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.
Detailed description
This is an open-label, single-dose, parallel group study to evaluate the PK, safety, tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4 groups based on renal function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: End Stage Renal Disease (ESRD) | Experimental | Drug: MEDI0382Subjects with CrCl <20ml/min will receive MEDI0382 administered subcutaneously |
| Group 2: Severe and ESRD Subjects | Experimental | Drug: MEDI0382Subjects with CrCl >20 and < 30 ml/min will receive MEDI0382 administered subcutaneously |
| Group 3: Healthy Subjects | Active comparator | Drug: MEDI0382Subjects with CrCl >90 ml/min will receive MEDI0382 administered subcutaneously |
| Group 4: Moderate Renal Disease | Experimental | Drug: MEDI0382Subjects with CrCl > or equal to 30 and < 60 mL/min will receive MEDI0382 administered subcutaneously |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must provide written informed consent
- BMI greater than or equal to 17 and less than or equal to 40 kg/m2
- Creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 mL/min)
- Females of childbearing potential must use a highly effective form of contraception.
Key exclusion criteria (5 listed)
- Any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety.
- Subjects on dialysis
- Subjects with pancreatitis
- Renal transplant subjects
- Females pregnant or lactating
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 |
|---|---|---|
| MEDI0382MEDI0382 administered subcutaneously | Drug | Group 1: End Stage Renal Disease (ESRD), Group 2: Severe and ESRD Subjects, Group 3: Healthy Subjects, Group 4: Moderate Renal Disease |
Primary outcome
Maximum Observed Concentration of MEDI0382 (Cmax)
Time frame: 0-48 hours
The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data
Area under the Concentration Time Curve (AUC) of MEDI0382
Time frame: 0-48 hours
The area under the plasma concentration-time curve to 48 hours concentration determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations
8 secondary outcomes
Time to maximum observed concentration (Tmax)
Time frame: 0-48 hours
apparent clearance (Cl/F)
Time frame: 0-48 hours
AUCinf
Time frame: 0-48 hours
Half-life (T1/2)
Time frame: 0-48 hours
Anti-drug Antibody (ADA) titer
Time frame: Day -1 to day 28
Number of subjects with Adverse Events
Time frame: Study onset till 28 days post dosing
Number of subjects with Adverse Events
Time frame: Study onset till 28 days post dosing
Number of subjects with Adverse Events
Time frame: Study onset till 28 days post dosing
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 1 May 2018.
- Derived from this study: PubMed 37140727Klein G, Petrone M, Yang Y, Hoang T, Hazlett S, Hansen L, Flor A. Pharmacokinetics and Safety of Cotadutide, a GLP-1 and Glucagon Receptor Dual Agonist, in Individuals with Renal Impairment: A Single-Dose, Phase I, Bridging Study. Clin Pharmacokinet. 2023 Jun;62(6):881-890. doi: 10.1007/s40262-023-01239-1. Epub 2023 May 4.
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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.
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 MEDI0382 in people with Renal Insufficiency, run by MedImmune LLC 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 4 inclusion and 5 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 1 May 2018. 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, New Zealand. 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?
Maximum Observed Concentration of MEDI0382 (Cmax) (time frame: 0-48 hours). The study lists 2 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 NCT03235375, which also lists 1 linked publication.
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 1 May 2018.