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A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Medical Investigations, Inc.
Little Rock, Arkansas, 72205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Nephropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based
on an eGFR of 20-75 mL/min/1.73m2.

- Evidence of persistent, overt albuminuria; defined as a UACR >=300 mg/g (>=33.9
mg/mmol) or UPCR >=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.

- Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB,
which may also include an aldosterone antagonist in double RAAS but not triple RAAS
inhibitor therapy) for at least 3 months before screening and to be maintained for the
duration of the study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.

- Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD),
severe peripheral vascular disease (PVD) or obstructive uropathy.

NCT01712061
Pfizer
Completed
A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy

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A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Evaluate The Efficacy And Safety Of Once-daily Administration Of A Chemokine Ccr2/5 Receptor Antagonist (Pf-04634817) In Adults With Type 2 Diabetes And Overt Nephropathy
The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a surrogate for improved glomerular filtration.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetic Nephropathy
  • Drug: PF-04634817
    Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
  • Drug: Placebo
    Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
  • Active Comparator: Arm 1 PF-04634817
    Intervention: Drug: PF-04634817
  • Placebo Comparator: Arm 2 Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
226
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based on an eGFR of 20-75 mL/min/1.73m2.
  • Evidence of persistent, overt albuminuria; defined as a UACR >=300 mg/g (>=33.9 mg/mmol) or UPCR >=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.
  • Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB, which may also include an aldosterone antagonist in double RAAS but not triple RAAS inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study.

Exclusion Criteria:

  • Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
  • Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Canada,   Germany,   Hong Kong,   Italy,   Korea, Republic of,   Malaysia,   Peru,   Poland,   Puerto Rico,   Romania,   Spain,   United States
 
 
NCT01712061
B1261007
2012-003332-23 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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