Clinical trial NCT01447147: A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Type 2 Diabetes Mellitus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-10-06
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.

Detailed description: The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy based on subject incidence of adverse events.

The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes and renal medications.

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

Eligibility criteria: Key Inclusion Criteria:

* Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association \[ADA\] criteria)
* Residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening (Albumin:creatinine ratio \[ACR\] of 100 to 3000 mg/g creatinine, inclusive)
* 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 ACE inhibitor or ARB for at least 8 weeks prior to screening, but subjects must not be on both an ACE inhibitor and an ARB
* Hemoglobin A1c (HbA1c) \> 6.0% but not \> 10.0% and 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)

Primary outcomes:
measure: Subject incidence of adverse events
timeFrame: Up to 365 days
Secondary outcomes:
measure: Change from baseline in first morning urinary albumin:creatinine ratio (ACR)
timeFrame: Up to 365 days
Other outcomes:
Locations:
city: Antwerp
country: Belgium
city: Brussels
country: Belgium
city: Edegem
country: Belgium
city: Ghent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Roeselare
country: Belgium
city: Beroun
country: Czechia
city: Brno
country: Czechia
city: Hlucin
country: Czechia
city: Neratovice
country: Czechia
city: Novy Jicin
country: Czechia
city: NZdar Nad Sazavou
country: Czechia
city: Pardubice
country: Czechia
city: Prague
country: Czechia
city: Prelouc
country: Czechia
city: Rakovnik
country: Czechia
city: Slany
country: Czechia
city: Trebic
country: Czechia
city: Uhersky Brod
country: Czechia
city: Unicov
country: Czechia
city: Berlin
country: Germany
city: Bosenheim
country: Germany
city: Deggingen
country: Germany
city: Dresden
country: Germany
city: Erlangen
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Heilbronn
country: Germany
city: Hoyerswerda
country: Germany
city: Koeln
country: Germany
city: Munich
country: Germany
city: Neuwied
country: Germany
city: Nuernberg
country: Germany
city: Pirna
country: Germany
city: Potsdam
country: Germany
city: Saarlouis
country: Germany
city: Speyer
country: Germany
city: Wiesbaden
country: Germany
city: Baja
country: Hungary
city: Balatonfuered
country: Hungary
city: Bekescsaba
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Eger
country: Hungary
city: Gyula
country: Hungary
city: Hatvan
country: Hungary
city: Kaposvar
country: Hungary
city: Kisvarda
country: Hungary
city: Satoraljaujhely
country: Hungary
city: Szekszard, Tolna
country: Hungary
city: Szikszo
country: Hungary
city: Bialystok
country: Poland
city: Ciechanow
country: Poland
city: Gdansk
country: Poland
city: Grodzisk Mazowiecki
country: Poland
city: Krakow
country: Poland
city: Poznan
country: Poland
city: Radom
country: Poland
city: Rzeszow
country: Poland
city: Szczecin
country: Poland
city: Warsaw
country: Poland
city: Wroclaw
country: Poland
city: Bath
country: United Kingdom
city: Belfast
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Bristol
country: United Kingdom
city: Chester
country: United Kingdom
city: Coventry
country: United Kingdom
city: Doncaster
country: United Kingdom
city: Edmonton
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Livingston
country: United Kingdom
city: Londonderry
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesbrough
country: United Kingdom
city: Norfolk
country: United Kingdom
city: Preston
country: United Kingdom
city: Salford
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Swansea
country: United Kingdom
city: Welwyn Garden City
country: United Kingdom
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: de Zeeuw D, Bekker P, Henkel E, Hasslacher C, Gouni-Berthold I, Mehling H, Potarca A, Tesar V, Heerspink HJ, Schall TJ; CCX140-B Diabetic Nephropathy Study Group. The effect of CCR2 inhibitor CCX140-B on residual albuminuria in patients with type 2 diabetes and nephropathy: a randomised trial. Lancet Diabetes Endocrinol. 2015 Sep;3(9):687-96. doi: 10.1016/S2213-8587(15)00261-2. Epub 2015 Aug 9.
citation: 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.