Trial · NCT01488877
A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
NCT01488877, Phase 1, Terminated, Pfizer; results first posted 2013-09-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy. Trials, record NCT01488877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01488877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
- NCT number
- NCT01488877
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Type 2 Diabetic Nephropathy
- Interventions
- PF-03882845, PF-03882845, PF-03882845, Spironolactone, placebo
- First posted
- 2011-12-08
- Last updated
- 2013-10-29
- Results first posted
- 2013-09-23
- Limitations and caveats
Study was terminated prematurely; this was based on a strategic decision by the sponsor to terminate further development of this compound for proposed indication. The study was not terminated for safety or lack of efficacy reasons.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Serum Potassium at Day 8 | Baseline, Day 7, 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. |
| Primary | Change From Baseline in Serum Potassium at Day 15 | Baseline, Day 14, 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. |
| Primary | Number of Participants With Confirmed and Severe Hyperkalemia | Baseline up to Day 15 | 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. |
| Secondary | Plasma Pharmacokinetic (PK) Parameters | 0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14 | 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. |
| Secondary | Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15 | Day 1 (Baseline), 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. |
| Secondary | Change From Baseline in Sitting Pulse Rate at Day 15 | Day 1 (Baseline), 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Serum Potassium at Day 8 | Baseline, Day 7, 8 | Safety analysis set included all participants who received at least 1 dose of study medication. | milliequivalent/liter (mEq/L) | MEDIAN |
| PRIMARY | Change From Baseline in Serum Potassium at Day 15 | Baseline, Day 14, 15 | Safety analysis set included all participants who received at least 1 dose of study medication. | mEq/L | MEDIAN |
| PRIMARY | Number of Participants With Confirmed and Severe Hyperkalemia | Baseline up to Day 15 | Safety analysis set included all participants who received at least 1 dose of study medication. | participants | NUMBER |
| SECONDARY | Plasma Pharmacokinetic (PK) Parameters | 0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14 | Data for all pre-specified PK parameters were not analyzed because a decision was made to prematurely terminate the study. | ||
| SECONDARY | Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15 | Day 1 (Baseline), 15 | Safety analysis set included all participants who received at least 1 dose of study medication. | millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Sitting Pulse Rate at Day 15 | Day 1 (Baseline), 15 | Safety analysis set included all participants who received at least 1 dose of study medication. | beats per minute (bpm) | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Serum Potassium at Day 8 | Placebo | Baseline | 4.78 | Full Range 4.2 to 5.0 | milliequivalent/liter (mEq/L) |
| Change From Baseline in Serum Potassium at Day 8 | PF-03882845 3 mg | Baseline | 4.90 | Full Range 4.8 to 5.1 | milliequivalent/liter (mEq/L) |
| Change From Baseline in Serum Potassium at Day 8 | Placebo | Change at Day 8 | 0.20 | Full Range -0.3 to 0.5 | milliequivalent/liter (mEq/L) |
| Change From Baseline in Serum Potassium at Day 8 | PF-03882845 3 mg | Change at Day 8 | 0.25 | Full Range 0.2 to 0.7 | milliequivalent/liter (mEq/L) |
| Change From Baseline in Serum Potassium at Day 15 | Placebo | 0.40 | Full Range -0.0 to 1.1 | mEq/L | |
| Change From Baseline in Serum Potassium at Day 15 | PF-03882845 3 mg | 0.25 | Full Range -0.2 to 0.9 | mEq/L | |
| Number of Participants With Confirmed and Severe Hyperkalemia | Placebo | Confirmed Hyperkalemia | 2 | participants | |
| Number of Participants With Confirmed and Severe Hyperkalemia | PF-03882845 3 mg | Confirmed Hyperkalemia | 5 | participants | |
| Number of Participants With Confirmed and Severe Hyperkalemia | Placebo | Severe Hyperkalemia | 0 | participants | |
| Number of Participants With Confirmed and Severe Hyperkalemia | PF-03882845 3 mg | Severe Hyperkalemia | 1 | participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Randomization | STARTED | PF-03882845 Placebo | 1 | |
| Initial Randomization | STARTED | PF-03882845 3 mg | 5 | |
| Initial Randomization | STARTED | Spironolactone Placebo | 0 | |
| Initial Randomization | COMPLETED | PF-03882845 Placebo | 1 | |
| Initial Randomization | COMPLETED | PF-03882845 3 mg | 5 | |
| Initial Randomization | COMPLETED | Spironolactone Placebo | 0 | |
| Initial Randomization | NOT COMPLETED | PF-03882845 Placebo | 0 | |
| Initial Randomization | NOT COMPLETED | PF-03882845 3 mg | 0 | |
| Initial Randomization | NOT COMPLETED | Spironolactone Placebo | 0 | |
| Re-randomization | STARTED | PF-03882845 Placebo | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site injury | General disorders | Placebo | 0 | 4 | |
| other | Injection site injury | General disorders | PF-03882845 3 mg | 1 | 5 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Placebo | 1 | 4 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | PF-03882845 3 mg | 0 | 5 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 4 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | PF-03882845 3 mg | 1 | 5 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 4 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | PF-03882845 3 mg | 0 | 5 | |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 4 | |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | PF-03882845 3 mg | 0 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | PF-03882845 3 mg | ||
| Total, other adverse events | Placebo | 1 | 4 |
| Total, other adverse events | PF-03882845 3 mg | 2 | 5 |
| Total, serious adverse events | Placebo | 0 | 4 |
| Total, serious adverse events | PF-03882845 3 mg | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PF-03882845 3 mg vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01488877
GET https://conductscience.org/api/trials/v1/NCT01488877/results?page=2