A study in Patients with Diabetic Kidney Disease

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 - N/A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020404-29-HU

Enrollment

400

Registered

2011-01-31

Start date

2011-04-08

Completion date

Unknown

Last updated

2014-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Diabetic Kidney Disease due to Type 1 or Type 2 Diabetes MedDRA version: 15.0 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Anti-humanTGF-ß1, subclass IgG4, humanized antibody LA307 Product Code: LY2382770 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: N/A Current Sponsor code: LY

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men and women not of childbearing potential =25 years of age with type 1 or type 2 diabetes mellitus and either an SCr of 1.3 to 3.3 mg/dL (115 to 291 µmol/L) in women and 1.5 to 3.5 mg/dL (132 to 309 µmol/L) in men, or an estimated glomerular filtration rate (eGFR) of 20 to 60 mL/min/1.73m2, and a 24-hour urine PCR of =800 mg/g (=91 mg/mmol), despite equilibration for =2 months on an appropriate dose of either ACEi or ARB therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Chronic kidney disease (CKD) from causes other than presumed DKD, uncontrolled hypertension, unstable cardiovascular disease, cancer or predisposing conditions, autoimmune disease, chronic inflammatory disease, hepatitis B or C infection, cirrhosis or significant liver disease, systemic immunosuppression therapy, and recent gastrointestinal bleeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 patients treated with angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) administered monthly by subcutaneous injection for 1 year is more effective than placebo at slowing the progressive loss of kidney function, as measured by Serum Creatinine (SCr) change from baseline. ;Secondary Objective: To compare LY2382770 to placebo for: - safety and tolerability; - serum creatinine slope of change from baseline over time; - first morning urine protein/creatinine ratio change from baseline to endpoint; - Biomarkers related to efficacy To evaluate PK of LY2382770 and to determine within and between subject variability To explore population PK and PD relationships of LY2382770. To evaluate the frequency and clinical consequences of endogenous antibodies to LY2382770 ;Primary end point(s): Primary Outcome Measures: Change in Serum Creatinine from baseline to 12 month endpoint [Time Frame: Baseline, 12 months]. ;Timepoint(s) of evaluation of this end point: Serum Creatinine will be tested at: • Screening visit • Randomization visit (baseline) which can be done up to 4 weeks after the Screening visit • Visit 4 (8 weeks post baseline) • Visit 6 (17 weeks post baseline) • Visit 13 (34 weeks post baseline) • Visit 15 (43 weeks post baseline) • Visit 17 (51 weeks post baseline) • Visit 19 (64 weeks post baseline)	—

Measure

Time frame

Main Objective: 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 patients treated with angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) administered monthly by subcutaneous injection for 1 year is more effective than placebo at slowing the progressive loss of kidney function, as measured by Serum Creatinine (SCr) change from baseline. ;Secondary Objective: To compare LY2382770 to placebo for: - safety and tolerability; - serum creatinine slope of change from baseline over time; - first morning urine protein/creatinine ratio change from baseline to endpoint; - Biomarkers related to efficacy To evaluate PK of LY2382770 and to determine within and between subject variability To explore population PK and PD relationships of LY2382770. To evaluate the frequency and clinical consequences of endogenous antibodies to LY2382770 ;Primary end point(s): Primary Outcome Measures: Change in Serum Creatinine from baseline to 12 month endpoint [Time Frame: Baseline, 12 months]. ;Timepoint(s) of evaluation of this end point: Serum Creatinine will be tested at: • Screening visit • Randomization visit (baseline) which can be done up to 4 weeks after the Screening visit • Visit 4 (8 weeks post baseline) • Visit 6 (17 weeks post baseline) • Visit 13 (34 weeks post baseline) • Visit 15 (43 weeks post baseline) • Visit 17 (51 weeks post baseline) • Visit 19 (64 weeks post baseline)

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Secondary

Measure	Time frame
Secondary end point(s): Compare LY2382770 to placebo for: 1- Safety and efficacy 2 - First morning Urine Protein/Creatinine Ratio change from baseline to 12 month endpoint 3 - biomarkers related to efficacy 4 - Serum creatinine slope of change from baseline through 12 months Also: 5 - Evaluation of PK properties of LY2382770 6 - Explore PK and PD relationship of LY2382770 7 - Evaluate the frequency and clinical consequences of endogenous antibodies to LY2382770;Timepoint(s) of evaluation of this end point: 1 - Safety and Efficacy AEs collected at all visits 2 - First morning Urine Protein/Creatinine Ratio change from baseline to 12 month endpoint data collected at: - Screening visit - Visit 18 3 - biomarkers related to efficacy Visits 2, 10 and 11 4 - Serum creatinine slope of change from baseline through 12 months - Visit 1, 2, 4, 6, 13, 15, 17 and 19 5 - Population PK (Attachment GFRF.4b.) - Visits 3, 4, 5, 7, 8, 9, 10, 11, 14, 16, 18 6 - PD (as for #2 and #4 above) and PK as for #5 above. Detailed further in Protocol Schedule of Events 7 - Antibodies Visits 1, 5, 11, 14 and 18	—

Measure

Time frame

Secondary end point(s): Compare LY2382770 to placebo for: 1- Safety and efficacy 2 - First morning Urine Protein/Creatinine Ratio change from baseline to 12 month endpoint 3 - biomarkers related to efficacy 4 - Serum creatinine slope of change from baseline through 12 months Also: 5 - Evaluation of PK properties of LY2382770 6 - Explore PK and PD relationship of LY2382770 7 - Evaluate the frequency and clinical consequences of endogenous antibodies to LY2382770;Timepoint(s) of evaluation of this end point: 1 - Safety and Efficacy AEs collected at all visits 2 - First morning Urine Protein/Creatinine Ratio change from baseline to 12 month endpoint data collected at: - Screening visit - Visit 18 3 - biomarkers related to efficacy Visits 2, 10 and 11 4 - Serum creatinine slope of change from baseline through 12 months - Visit 1, 2, 4, 6, 13, 15, 17 and 19 5 - Population PK (Attachment GFRF.4b.) - Visits 3, 4, 5, 7, 8, 9, 10, 11, 14, 16, 18 6 - PD (as for #2 and #4 above) and PK as for #5 above. Detailed further in Protocol Schedule of Events 7 - Antibodies Visits 1, 5, 11, 14 and 18

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Countries

Australia, Czech Republic, France, Hungary, Israel, Puerto Rico, United States

Contacts

Public ContactClinical Trial Information

Eli Lilly and Company

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026