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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03235375




Registration number
NCT03235375
Ethics application status
Date submitted
27/07/2017
Date registered
1/08/2017
Date last updated
1/05/2018

Titles & IDs
Public title
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects
Scientific 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
Secondary ID [1] 0 0
D5670C00008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Insufficiency 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MEDI0382

Experimental: Group 1: End Stage Renal Disease (ESRD) - Subjects with CrCl <20ml/min will receive MEDI0382 administered subcutaneously

Experimental: Group 2: Severe and ESRD Subjects - Subjects with CrCl >20 and < 30 ml/min will receive MEDI0382 administered subcutaneously

Active Comparator: Group 3: Healthy Subjects - Subjects with CrCl >90 ml/min will receive MEDI0382 administered subcutaneously

Experimental: Group 4: Moderate Renal Disease - Subjects with CrCl > or equal to 30 and < 60 mL/min will receive MEDI0382 administered subcutaneously


Treatment: Drugs: MEDI0382
MEDI0382 administered subcutaneously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Observed Concentration of MEDI0382 (Cmax)
Timepoint [1] 0 0
0-48 hours
Primary outcome [2] 0 0
Area under the Concentration Time Curve (AUC) of MEDI0382
Timepoint [2] 0 0
0-48 hours
Secondary outcome [1] 0 0
Time to maximum observed concentration (Tmax)
Timepoint [1] 0 0
0-48 hours
Secondary outcome [2] 0 0
apparent clearance (Cl/F)
Timepoint [2] 0 0
0-48 hours
Secondary outcome [3] 0 0
AUCinf
Timepoint [3] 0 0
0-48 hours
Secondary outcome [4] 0 0
Half-life (T1/2)
Timepoint [4] 0 0
0-48 hours
Secondary outcome [5] 0 0
Anti-drug Antibody (ADA) titer
Timepoint [5] 0 0
Day -1 to day 28
Secondary outcome [6] 0 0
Number of subjects with Adverse Events
Timepoint [6] 0 0
Study onset till 28 days post dosing
Secondary outcome [7] 0 0
Number of subjects with Adverse Events
Timepoint [7] 0 0
Study onset till 28 days post dosing
Secondary outcome [8] 0 0
Number of subjects with Adverse Events
Timepoint [8] 0 0
Study onset till 28 days post dosing

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Basic Science
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2018
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Kiel
Country [2] 0 0
Germany
State/province [2] 0 0
München
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03235375
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03235375