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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01712061
First received: October 19, 2012
Last updated: September 22, 2015
Last verified: September 2015
Results First Received: September 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetic Nephropathy
Interventions: Drug: PF-04634817
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The primary entry criterion for participants was based on presence of macroalbuminuria (urine albumin to creatinine ratio [UACR] greater than or equal to (>=)300 milligrams per gram (mg/g).

Reporting Groups
  Description
PF-04634817 150 mg Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
PF-04634817 200 mg Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
Placebo Participants were dosed orally with matching placebo tablets QD for 12 weeks.

Participant Flow:   Overall Study
    PF-04634817 150 mg   PF-04634817 200 mg   Placebo
STARTED   30   140   56 
COMPLETED   20   114   45 
NOT COMPLETED   10   26   11 
Adverse Event                4                9                5 
Death                0                0                1 
Lost to Follow-up                1                0                1 
Did Not Meet Entrance Criteria                4                6                3 
Medication Error Without Associated AE                0                1                0 
Withdrawal by Subject                1                7                1 
Unspecified                0                3                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PF-04634817 200 mg/150 mg Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
Placebo Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   PF-04634817 200 mg/150 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 170   56   226 
Age, Customized 
[Units: Participants]
     
Less than (<) 18 years   0   0   0 
18-44 years   3   0   3 
45-64 years   78   31   109 
>=65 years   89   25   114 
Gender 
[Units: Participants]
     
Female   36   7   43 
Male   134   49   183 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Change From Baseline in UACR at Weeks 4, 8 and 16   [ Time Frame: Baseline, Weeks 4, 8 and 16 ]

3.  Secondary:   Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16   [ Time Frame: Baseline, Weeks 4, 8, 12 and 16 ]

4.  Secondary:   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   [ Time Frame: Baseline, Week 1, 4, 8, 12 and 16 ]

5.  Secondary:   Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16   [ Time Frame: Baseline, Week 12, and Week 16 ]

6.  Secondary:   Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16   [ Time Frame: Baseline, Week 1, 4, 8, 12 and 16 ]

7.  Secondary:   Change From Baseline in Serum Cystatin C at Weeks 12 and 16   [ Time Frame: Baseline, Week 12, and Week 16 ]

8.  Secondary:   Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16   [ Time Frame: Baseline, Weeks 4, 8, 12 and 16 ]

9.  Secondary:   Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12   [ Time Frame: 1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12 ]

10.  Other Pre-specified:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16   [ Time Frame: Baseline, Weeks 1, 4, 8, 12 and 16 ]

11.  Other Pre-specified:   Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16   [ Time Frame: Baseline, Weeks 1, 4, 8, 12 and 16 ]

12.  Other Pre-specified:   Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16   [ Time Frame: Baseline, Weeks 1, 4, 8, 12 and 16 ]

13.  Other Pre-specified:   Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern   [ Time Frame: Baseline up to Week 16 (follow-up visit) ]

14.  Other Pre-specified:   Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings   [ Time Frame: Baseline, Weeks 1, 4 and 12 ]

15.  Other Pre-specified:   Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 28 days after last study drug administration ]

16.  Other Pre-specified:   Number of Participants With Increased Fasting Blood Glucose   [ Time Frame: Baseline up to Week 16 (follow-up visit) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01712061     History of Changes
Other Study ID Numbers: B1261007
2012-003332-23 ( EudraCT Number )
Study First Received: October 19, 2012
Results First Received: September 22, 2015
Last Updated: September 22, 2015
Health Authority: United States: Food and Drug Administration