A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria

NCT ID: NCT01440257

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-09-30

Brief Summary

The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to study the safety and efficacy of the medication in this patient population.

Detailed Description

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Conditions

Diabetic Nephropathy; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo (Group A)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules once daily

Active study medication (Group B)

CCX140-B

Group Type: EXPERIMENTAL

CCX140-B

Intervention Type: DRUG

CCX140-B capsules once daily (Group B)

Interventions

Placebo

Placebo capsules once daily

Intervention Type: DRUG

CCX140-B

CCX140-B capsules once daily (Group B)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria), and treated with oral antidiabetic drugs
• Albumin:creatinine ratio (ACR) of 200 to 3000 mg/g creatinine, inclusive, based on two values obtained from two first morning urine samples taken on two separate days during the screening period
• Estimated glomerular filtration rate based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease [MDRD] equation) of ≥ 25 mL/min/1.73 m(2)
• Must be on a stable dose of an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening
• Fasting plasma glucose less than 270 mg/dL at screening

Exclusion Criteria

• Type 1 diabetes mellitus or history of diabetic ketoacidosis
• Previous renal transplant or known non-diabetic renal disease, except related to hypertension
• Undergone renal dialysis at any time in the past
• Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
• Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
• Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (NSAID) treatment within 2 weeks of screening
• Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
• Poorly-controlled blood pressure (systolic blood pressure >155 or diastolic blood pressure >95, with blood pressure measured in the seated position after at least 5 minutes of rest)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Centre for Human Drug Research

Leiden, , Netherlands

Countries

Netherlands

References

Sullivan T, Miao Z, Dairaghi DJ, Krasinski A, Wang Y, Zhao BN, Baumgart T, Ertl LS, Pennell A, Seitz L, Powers J, Zhao R, Ungashe S, Wei Z, Boring L, Tsou CL, Charo I, Berahovich RD, Schall TJ, Jaen JC. CCR2 antagonist CCX140-B provides renal and glycemic benefits in diabetic transgenic human CCR2 knockin mice. Am J Physiol Renal Physiol. 2013 Nov 1;305(9):F1288-97. doi: 10.1152/ajprenal.00316.2013. Epub 2013 Aug 28.

Reference Type: DERIVED

PMID: 23986513 (View on PubMed)

Other Identifiers

CL007_140

Identifier Type: -

Identifier Source: org_study_id