A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria (NCT01440257)

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Study 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.

Read the detailed description

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

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Conditions studied

Diabetic Nephropathy
Type 2 Diabetes Mellitus

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03

In context

Diabetic Nephropathies

534 studies on the registry are indexed under Diabetic Nephropathies; 107 are open to participants now.

This study's enrollment of 20 is below the median of 80 across 377 interventional studies indexed under Diabetic Nephropathies.

Browse Diabetic Nephropathies studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key 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

Key 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)

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Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 20 participants (actual)

Study arms

Placebo comparator
Placebo (Group A)
Drug: Placebo
Experimental
Active study medication (Group B)
CCX140-B
Drug: CCX140-B

Interventions

DrugPlacebo
Placebo capsules once daily
DrugCCX140-B
CCX140-B capsules once daily (Group B)

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What researchers measure

Primary outcomes

Change from baseline in 24-hour urinary albumin excretion
The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary albumin excretion by measuring change from baseline in 24-hour urinary albumin excretion.
Time frame: 84 days
Subject incidence of adverse events
The primary safety objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with type 2 diabetes mellitus (T2DM) with albuminuria.
Time frame: 84 days

Secondary outcomes

Change from baseline in hemoglobin A1c
Time frame: 84 days

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Study locations

1 site

Centre for Human Drug Research
Leiden, Netherlands

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References and documents

Publications

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. PubMed 23986513 ↗

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Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID: NCT01440257
Lead sponsor: Amgen
Responsible party: Sponsor
First posted: Sep 26, 2011
Start date: Sep 2011
Primary completion: Feb 2013
Completion: Sep 2013
Last update: Feb 27, 2025

Study contacts

MD

study director · Amgen

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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