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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01712061




Registration number
NCT01712061
Ethics application status
Date submitted
19/10/2012
Date registered
23/10/2012
Date last updated
21/10/2015

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2012-003332-23
Secondary ID [2] 0 0
B1261007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-04634817
Treatment: Drugs - Placebo

Active comparator: Arm 1 PF-04634817 -

Placebo comparator: Arm 2 Placebo -


Treatment: Drugs: PF-04634817
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function

Treatment: Drugs: Placebo
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Change From Baseline in UACR at Weeks 4, 8 and 16
Timepoint [1] 0 0
Baseline, Weeks 4, 8 and 16
Secondary outcome [2] 0 0
Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16
Timepoint [2] 0 0
Baseline, Weeks 4, 8, 12 and 16
Secondary outcome [3] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16
Timepoint [3] 0 0
Baseline, Week 1, 4, 8, 12 and 16
Secondary outcome [4] 0 0
Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16
Timepoint [4] 0 0
Baseline, Week 12, and Week 16
Secondary outcome [5] 0 0
Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16
Timepoint [5] 0 0
Baseline, Week 1, 4, 8, 12 and 16
Secondary outcome [6] 0 0
Change From Baseline in Serum Cystatin C at Weeks 12 and 16
Timepoint [6] 0 0
Baseline, Week 12, and Week 16
Secondary outcome [7] 0 0
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16
Timepoint [7] 0 0
Baseline, Weeks 4, 8, 12 and 16
Secondary outcome [8] 0 0
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12
Timepoint [8] 0 0
1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
226
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Department of Nephrology - New Lambton
Recruitment hospital [3] 0 0
Westmead Hospital, Department of Renal Medicine - Westmead
Recruitment hospital [4] 0 0
Sunshine Coast Hospital & Health Service - Nambour
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4560 - Nambour
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arkansas
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United States of America
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California
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Colorado
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Florida
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Illinois
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nebraska
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Ponce
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Rio Piedras
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Romania
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jud. Bihor
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Bucuresti
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Ploiesti
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01712061
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01712061