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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01113801




Registration number
NCT01113801
Ethics application status
Date submitted
28/04/2010
Date registered
30/04/2010

Titles & IDs
Public title
A Study in Participants With Diabetic Kidney Disease
Scientific title
A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY2382770 in Patients With Diabetic Kidney Disease Due to Type 1 or Type 2 Diabetes
Secondary ID [1] 0 0
H9V-MC-GFRF
Secondary ID [2] 0 0
10168
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Kidney Disease 0 0
Diabetic Nephropathy 0 0
Diabetic Glomerulosclerosis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY2382770
Treatment: Drugs - Placebo

Placebo comparator: Placebo -

Experimental: 2 mg LY2382770 -

Experimental: 10 mg LY2382770 -

Experimental: 50 mg LY2382770 -


Treatment: Drugs: LY2382770
Subcutaneous injection given monthly for 12 months

Treatment: Drugs: Placebo
Subcutaneous injection given monthly for 12 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint
Timepoint [1] 0 0
Baseline, 12 months
Secondary outcome [1] 0 0
Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint
Timepoint [1] 0 0
Baseline, 12 months
Secondary outcome [2] 0 0
Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration -Time Curve (AUC ) Over a Dosing Interval
Timepoint [2] 0 0
Baseline through 12 months (samples collected pre and/or postdose at monthly intervals)
Secondary outcome [3] 0 0
Log Transformed (ln) Serum Creatinine Slope of Change From Baseline Through 12 Months
Timepoint [3] 0 0
Baseline through 12 months
Secondary outcome [4] 0 0
Estimated Glomerular Filtration Rate (eGFR) Slope of Change From Baseline Through 12 Months
Timepoint [4] 0 0
Baseline through 12 months

Eligibility
Key inclusion criteria
Main

* Participants with chronic kidney disease presumed due to diabetes Type 1 or Type 2
* Participants with certain levels of kidney function - serum creatinine (SCr) 1.3 to 3.3 mg/dl (115 to 291 micromol/L) inclusive for women and 1.5 to 3.5 mg/dl (132 to 309 micromol/L) inclusive for men, or an estimated glomerular filtration rate (eGFR) 20 to 60 mL/min/1.73 m²
* Participants with protein in the urine - 24-hour urine protein/creatinine ratio (PCR) greater than or equal to 800 mg/g (greater than or equal to 91 mg/mmol).
* Participants must be on a stable and acceptable dose of an ACE (angiotensin-converting enzyme) inhibitor or an ARB (angiotensin II receptor blocker), or not able to tolerate these medications.

Main
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Female participants who can become pregnant, are pregnant or breastfeeding
* Participants who have any of the following medical conditions (the site research staff will discuss these criteria and determine a participant's ability to participate)

* Chronic inflammatory or autoimmune diseases
* Chronic Kidney Disease from causes other than diabetes
* An organ transplant
* Too high a blood pressure
* Viral Hepatitis B or C liver infection, liver cirrhosis, or significant liver disease
* Recent gastrointestinal bleeding
* Acute kidney injury within the 3 months before screening
* Major surgery within 3 months before screening or plan to have it during the study period
* HIV infection- the virus that causes AIDS
* Heart disease that is not considered stable
* Cancer that is too recent or other condition which poses too high a risk for developing cancer
* Required to take drugs that change the immune system

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
417
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Camperdown
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Concord
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Gosford
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Liverpool
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Adelaide
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Launceston
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Box Hill
Recruitment hospital [8] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Fitzroy
Recruitment hospital [9] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Heidelberg
Recruitment hospital [10] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Melbourne
Recruitment hospital [11] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Parkville
Recruitment hospital [12] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Reservoir
Recruitment hospital [13] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
7250 - Launceston
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment postcode(s) [12] 0 0
3073 - Reservoir
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
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Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
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Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
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Utah
Country [19] 0 0
United States of America
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Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Czechia
State/province [21] 0 0
Cesky Krumlov
Country [22] 0 0
Czechia
State/province [22] 0 0
Decin
Country [23] 0 0
Czechia
State/province [23] 0 0
Jilemnice
Country [24] 0 0
Czechia
State/province [24] 0 0
Liberec
Country [25] 0 0
Czechia
State/province [25] 0 0
Ostrava
Country [26] 0 0
Czechia
State/province [26] 0 0
Prague
Country [27] 0 0
Czechia
State/province [27] 0 0
Tabor
Country [28] 0 0
Czechia
State/province [28] 0 0
Teplice
Country [29] 0 0
France
State/province [29] 0 0
Grenoble
Country [30] 0 0
France
State/province [30] 0 0
Lyon
Country [31] 0 0
France
State/province [31] 0 0
Nanterre Cedex
Country [32] 0 0
France
State/province [32] 0 0
Valenciennes
Country [33] 0 0
France
State/province [33] 0 0
Vandoeuvre Les Nancy
Country [34] 0 0
Hungary
State/province [34] 0 0
Baja
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Hungary
State/province [35] 0 0
Balatonfured
Country [36] 0 0
Hungary
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Budapest
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Hungary
State/province [37] 0 0
Gyongyos
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Hungary
State/province [38] 0 0
Gyor
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Hungary
State/province [39] 0 0
Kaposvar
Country [40] 0 0
Hungary
State/province [40] 0 0
Nagykanizsa
Country [41] 0 0
Hungary
State/province [41] 0 0
Szeged
Country [42] 0 0
Hungary
State/province [42] 0 0
Szigetvar
Country [43] 0 0
Hungary
State/province [43] 0 0
Zalaegerszeg
Country [44] 0 0
Israel
State/province [44] 0 0
Ashkelon
Country [45] 0 0
Israel
State/province [45] 0 0
Hadera
Country [46] 0 0
Israel
State/province [46] 0 0
Haifa
Country [47] 0 0
Israel
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Holon
Country [48] 0 0
Israel
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Jerusalem
Country [49] 0 0
Israel
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Kfar Saba
Country [50] 0 0
Israel
State/province [50] 0 0
Nahariya
Country [51] 0 0
Israel
State/province [51] 0 0
Rehovot
Country [52] 0 0
Israel
State/province [52] 0 0
Safed
Country [53] 0 0
Israel
State/province [53] 0 0
Tel Aviv
Country [54] 0 0
Israel
State/province [54] 0 0
Tel Hashomer
Country [55] 0 0
Israel
State/province [55] 0 0
Zerifin
Country [56] 0 0
Puerto Rico
State/province [56] 0 0
Cidra
Country [57] 0 0
Puerto Rico
State/province [57] 0 0
Rio Piedras

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01113801