Diabetic Kidney DiseasePhase 2NCT01113801
A Study in Participants With Diabetic Kidney Disease
A Phase 2 study testing LY2382770 in people with Diabetic Kidney Disease and Diabetic Nephropathy, run by Eli Lilly and Company at 78 sites in 7 countries.
Trial summary
The purpose of this study is to determine if LY2382770 is safe and effective at protecting kidney function in participants with kidney disease due to diabetes. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Diabetic Kidney Disease, Diabetic Nephropathy, Diabetic Glomerulosclerosis
- What is being tested?
- LY2382770
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 417 participants
- Where
- 78 sitesin 7 countries
- Study dates
- Jul 2010to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- 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 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
Trial locations and contacts
78 sites in 7 countries.
78 sites in 7 countries
United States28 sites
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Atlanta, Georgia, 30342
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Beachwood, Ohio, 44122
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Bend, Oregon, 97701
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Chapel Hill, North Carolina, 27599
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Charlotte, North Carolina, 28207
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Dallas, Texas, 75390
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Denver, Colorado, 80220
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Durham, North Carolina, 27705
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Greenville, North Carolina, 27834
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Idaho Falls, Idaho, 83404
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Inglewood, California, 90301
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Kansas City, Missouri, 64128
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Kenner, Louisiana, 70065
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Los Angeles, California, 90073
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Lufkin, Texas, 75904
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Milwaukee, Wisconsin, 53295
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Northridge, California, 91324
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Omaha, Nebraska, 68131
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Orangeburg, South Carolina, 29118
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Phoenix, Arizona, 85012
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Port Charlotte, Florida, 33952
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Providence, Rhode Island, 02903
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Rockville, Maryland, 20852
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St. George, Utah, 84770
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Suffolk, Virginia, 23435
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Tampa, Florida, 33614
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Wichita, Kansas, 67214
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Winston-Salem, North Carolina, 27157
Australia13 sites
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Adelaide, South Australia, 5000
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Box Hill, Victoria, 3128
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Camperdown, New South Wales, 2050
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Concord, New South Wales, 2139
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Fitzroy, Victoria, 3065
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Gosford, New South Wales, 2250
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Heidelberg, Victoria, 3084
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Launceston, Tasmania, 7250
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Liverpool, New South Wales, 2170
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Melbourne, Victoria, 3004
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Nedlands, Western Australia, 6009
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Parkville, Victoria, 3050
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Reservoir, Victoria, 3073
Israel12 sites
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Ashkelon, 78278
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Hadera, 38100
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Haifa, 31096
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Holon, 58100
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Jerusalem, 91120
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Kfar Saba, 44281
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Nahariya, 22100
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Rehovot, 76100
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Safed, 13110
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Tel Aviv, 64239
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Tel HaShomer, 52621
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Tsrifin, 70300
Hungary10 sites
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Baja, 6500
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Balatonfüred, 8230
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Budapest, 1096
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Gyöngyös, 3200
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Győr, 9023
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Kaposvár, 7400
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Nagykanizsa, 8800
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Szeged, 6720
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Szigetvár, 7900
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Zalaegerszeg, 8900
Czechia8 sites
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Český Krumlov, 381 27
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Děčín, 405 99
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Jilemnice, 514 15
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Liberec, 460 63
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Ostrava, 703 84
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Prague, 181 02
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Tábor, 390 02
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Teplice, 415 01
France5 sites
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Grenoble, 38043
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Lyon, 69437
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Nanterre, 92014
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Valenciennes, 59322
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Vandœuvre-lès-Nancy, 54511
Puerto Rico2 sites
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Cidra, 00739
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Rio Piedras, 000935
About this study
Official 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
The purpose of this study is to determine if LY2382770 is safe and effective at protecting kidney function in participants with kidney disease due to diabetes.
Read the detailed description
The primary objective is to determine if LY2382770, administered monthly for 1 year, is more effective than placebo at slowing the progression of diabetic kidney disease in participants treated with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB).
- Being tested
- LY2382770, Placebo
- Keywords
- Chronic Kidney Disease, Diabetic Kidney Disease, End-Stage Renal Disease, Transforming Growth Factor beta 1 Monoclonal Antibody, Type 1 Diabetes, Type 2 Diabetes
- Medical subject headings
- Diabetic Nephropathies, Renal Insufficiency, Chronic, Kidney Failure, Chronic, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2382770Drug
Subcutaneous injection given monthly for 12 months
PlaceboDrug
Subcutaneous injection given monthly for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 mg LY2382770 | Experimental | Not described Receives: Drug: LY2382770 |
| 10 mg LY2382770 | Experimental | Not described Receives: Drug: LY2382770 |
| 50 mg LY2382770 | Experimental | Not described Receives: Drug: LY2382770 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint
Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
Measured: Baseline, 12 months
Secondary outcomes (4)
Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint
Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
Measured: Baseline, 12 months
Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration -Time Curve (AUC ) Over a Dosing Interval
Measured: Baseline through 12 months (samples collected pre and/or postdose at monthly intervals)
Log Transformed (ln) Serum Creatinine Slope of Change From Baseline Through 12 Months
Analysis of covariance (ANCOVA) model was used with treatment as fixed effects and baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
Measured: Baseline through 12 months
Estimated Glomerular Filtration Rate (eGFR) Slope of Change From Baseline Through 12 Months
Analysis of covariance (ANCOVA) model was used with treatment as fixed effects, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) ) log transformed (ln) as covariates.
Measured: Baseline through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2014
- Study completionJul 2014
Why it stopped: Interim Assessment: Lack of Efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113801
- Sponsor's protocol ID
- 10168
- Other IDs
- H9V-MC-GFRF
- Status last verified
- Sep 2019
- First submitted
- 28 Apr 2010
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01113801
- Acronym / sponsor ID
- 10168
- Keywords
- Chronic Kidney Disease, Diabetic Kidney Disease, End-Stage Renal Disease, Transforming Growth Factor beta 1 Monoclonal Antibody, Type 1 Diabetes, Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim Assessment: Lack of Efficacy
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if LY2382770 is safe and effective at protecting kidney function in participants with kidney disease due to diabetes.
Detailed description
The primary objective is to determine if LY2382770, administered monthly for 1 year, is more effective than placebo at slowing the progression of diabetic kidney disease in participants treated with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| 2 mg LY2382770 | Experimental | Drug: LY2382770 |
| 10 mg LY2382770 | Experimental | Drug: LY2382770 |
| 50 mg LY2382770 | Experimental | Drug: LY2382770 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| LY2382770Subcutaneous injection given monthly for 12 months | Drug | 10 mg LY2382770, 2 mg LY2382770, 50 mg LY2382770 |
| PlaceboSubcutaneous injection given monthly for 12 months | Drug | Placebo |
Primary outcome
Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint
Time frame: Baseline, 12 months
Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
4 secondary outcomes
Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint
Time frame: Baseline, 12 months
Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration -Time Curve (AUC ) Over a Dosing Interval
Time frame: Baseline through 12 months (samples collected pre and/or postdose at monthly intervals)
Log Transformed (ln) Serum Creatinine Slope of Change From Baseline Through 12 Months
Time frame: Baseline through 12 months
Estimated Glomerular Filtration Rate (eGFR) Slope of Change From Baseline Through 12 Months
Time frame: Baseline through 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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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.
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) study director
Eli Lilly and Company
78 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2382770 in people with Diabetic Kidney Disease and Diabetic Nephropathy, run by Eli Lilly and Company at 78 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Australia, Israel, Hungary, Czechia and 2 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint (time frame: Baseline, 12 months). 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 17 Sep 2019.