A Phase 1 interventional study of PF-03882845 and PF-03882845 in Type 2 Diabetic Nephropathy, sponsored by Pfizer. Terminated at 6 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-10-29.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845 in this population.
This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 6 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Drug: PF-03882845
25 mg once daily
Drug: Spironolactone
Placebo once daily
Other: placebo
3 mg tablet once daily
up to 10 mg tablet once daily
up to 30 mg once daily
spironolactone 25 mg once daily
placebo once daily
Change From Baseline in Serum Potassium at Day 8
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.
Time frame: Baseline, Day 7, 8
Change From Baseline in Serum Potassium at Day 15
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.
Time frame: Baseline, Day 14, 15
Number of Participants With Confirmed and Severe Hyperkalemia
Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (\>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level \>= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.
Time frame: Baseline up to Day 15
Plasma Pharmacokinetic (PK) Parameters
PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed.
Time frame: 0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14
Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15
Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements.
Time frame: Day 1 (Baseline), 15
Change From Baseline in Sitting Pulse Rate at Day 15
Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline.
Time frame: Day 1 (Baseline), 15
| Milestone | PF-03882845 Placebo | PF-03882845 3 mg | Spironolactone Placebo |
|---|---|---|---|
| Started | 1 | 5 | 0 |
| Completed | 1 | 5 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | PF-03882845 Placebo | PF-03882845 3 mg | Spironolactone Placebo |
|---|---|---|---|
| Started | 0 | 0 | 3 |
| Completed | 0 | 0 | 3 |
| Not completed | 0 | 0 | 0 |
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.
| milliequivalent/liter (mEq/L) | Placebo | PF-03882845 3 mg |
|---|---|---|
| Baseline | 4.78 (4.2 to 5.0) | 4.90 (4.8 to 5.1) |
| Change at Day 8 | 0.20 (-0.3 to 0.5) | 0.25 (0.2 to 0.7) |
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.
| mEq/L | Placebo | PF-03882845 3 mg |
|---|---|---|
| Change From Baseline in Serum Potassium at Day 15 | 0.40 (-0.0 to 1.1) | 0.25 (-0.2 to 0.9) |
Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (\>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level \>= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.
| participants | Placebo | PF-03882845 3 mg |
|---|---|---|
| Confirmed Hyperkalemia | 2 | 5 |
| Severe Hyperkalemia | 0 | 1 |
PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed.
No measurements were reported for this outcome.
Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements.
| millimeter of mercury (mmHg) | Placebo | PF-03882845 3 mg |
|---|---|---|
| Baseline: Systolic BP | 127.83 ± 19.601 | 125.53 ± 8.194 |
| Baseline: Diastolic BP | 74.92 ± 10.049 | 74.13 ± 5.237 |
| Change at Day 15: Systolic BP | -4.83 ± 22.599 | -3.20 ± 10.002 |
| Change at Day 15: Diastolic BP | -1.08 ± 9.398 | 1.00 ± 3.504 |
Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline.
| beats per minute (bpm) | Placebo | PF-03882845 3 mg |
|---|---|---|
| Baseline | 65.25 ± 6.757 | 74.47 ± 12.844 |
| Change at Day 15 | 6.17 ± 6.495 | -0.33 ± 8.788 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/4 (0%) | 1/4 (25%) |
| PF-03882845 3 mg | — | 0/5 (0%) | 2/5 (40%) |
| Event | Placebo | PF-03882845 3 mg |
|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 1/4 | 0/5 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 1/4 | 0/5 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 1/4 | 0/5 |
| Injection site injuryGeneral disorders | 0/4 | 1/5 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/4 | 1/5 |
| Age, Customized(participants) | Entire Study Population |
|---|---|
| less than (<) 18 years | 0 |
| 18 to 44 years | 0 |
| 45 to 64 years | 6 |
| greater than or equal to (>=) 65 years | 0 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 3 |
| Male | 3 |
This study is terminated, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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