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A Study in Patients With Diabetic Kidney Disease

This study is currently recruiting participants.
Verified May 2013 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01113801
First received: April 28, 2010
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to determine if LY2382770 is safe and effective at protecting kidney function in patients with kidney disease due to diabetes.


Condition Intervention Phase
Diabetic Kidney Disease
Diabetic Nephropathy
Diabetic Glomerulosclerosis
 Drug: LY2382770
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change in Serum Creatinine from baseline to 12 month endpoint [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Urine Protein/Creatinine Ratio from baseline to 12 month endpoint [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  • Population PK [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]
  • Serum creatinine slope of change from baseline through 12 months [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: July 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Subcutaneous injection given monthly for 12 months
Experimental: 2 mg LY2382770 Drug: LY2382770
Subcutaneous injection given monthly for 12 months
Experimental: 10 mg LY2382770 Drug: LY2382770
Subcutaneous injection given monthly for 12 months
Experimental: 50 mg LY2382770 Drug: LY2382770
Subcutaneous injection given monthly for 12 months

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 patients treated with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB).

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Patients with chronic kidney disease presumed due to diabetes Type 1 or Type 2
  • Patients 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 eGFR 20 to 60 mL/min/1.73 m2
  • Patients 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).
  • Patients 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 patients who can become pregnant, are pregnant or breastfeeding

  • Patients who have any of the following medical conditions (the site research staff will discuss these criteria and determine a patient'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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113801

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559

  Show 87 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01113801     History of Changes
Other Study ID Numbers: 10168, H9V-MC-GFRF
Study First Received: April 28, 2010
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Ministry of Health
Israel: Ministry of Health
European Union: European Medicines Agency
Poland: Ministry of Health
Hungary: National Institute of Pharmacy

Keywords provided by Eli Lilly and Company:
Chronic Kidney Disease
Diabetic Kidney Disease
End-Stage Renal Disease
 Transforming Growth Factor beta 1 Monoclonal Antibody
Type 1 Diabetes
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013