Trial · NCT02243306
Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis
NCT02243306, Phase 1, Completed, GlaxoSmithKline; results first posted 2019-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis. Trials, record NCT02243306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02243306
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis
- NCT number
- NCT02243306
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- GSK1278863
- First posted
- 2014-09-17
- Last updated
- 2019-04-09
- Other registries' IDs
- eudract:2014-001197-34
- Results first posted
- 2019-03-11
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14 | Serial blood samples were collected from participants at indicated time points for Pharmacokinetic (PK) analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. PK Population comprised of participants in the 'All Subjects' Population for whom a PK sample was obtained and analyzed. |
| Primary | AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-inf]) of GSK1278863 and Its Metabolites | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1 | Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2487818 and GSK2531398). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. |
| Primary | Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14 | Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Secondary | Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs) | Up to Day 24 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations, and is associated with liver injury and impaired liver function. Analysis was performed on All Subjects Population which comprised of all enrolled participants who received at least one dose of study treatment. |
| Secondary | Change From Baseline in Glucose, Calcium, Chloride, Carbon-dioxide (CO2), Potassium, Sodium and Urea Levels | Baseline and Day 17 | Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, calcium, chloride, CO2, potassium, sodium and urea. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed. |
| Secondary | Change From Baseline in Albumin and Protein Levels | Baseline and Day 17 | Blood samples were collected from participants to evaluate clinical chemistry parameters including albumin and protein. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed. |
| Secondary | Change From Baseline in Direct Bilirubin, Bilirubin, Creatinine and Urate Levels | Baseline and Day 17 | Blood samples were collected from participants to evaluate clinical chemistry parameters including direct bilirubin, bilirubin, creatinine and urate. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed. |
| Secondary | Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Aminotransferase (GGT) Levels | Baseline and Day 17 | Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, AST and GGT. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed. |
| Secondary | Change From Baseline in Alanine Aminotransferase (ALT) and Creatinine Kinase Levels | Baseline and Day 3, 7, 11, 14, 17 | Blood samples were collected from participants to evaluate clinical chemistry parameters including ALT and creatinine kinase. Change from Baseline in clinical chemistry parameters at Day 3, Day 7, Day 11, Day 14 and Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Secondary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Levels | Baseline and Day 17 | Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. NA indicates data is not available. Mean and standard deviation are presented. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14 | PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles). | Hour into nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-inf]) of GSK1278863 and Its Metabolites | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1 | PK Population | Hour into nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14 | PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles). | Nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs) | Up to Day 24 | All subjects Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Glucose, Calcium, Chloride, Carbon-dioxide (CO2), Potassium, Sodium and Urea Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | Millimoles per liter | MEAN |
| SECONDARY | Change From Baseline in Albumin and Protein Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | Gram per liter (g/L) | MEAN |
| SECONDARY | Change From Baseline in Direct Bilirubin, Bilirubin, Creatinine and Urate Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | Micromoles per liter | MEAN |
| SECONDARY | Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Aminotransferase (GGT) Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | International unit per liter (IU/L) | MEAN |
| SECONDARY | Change From Baseline in Alanine Aminotransferase (ALT) and Creatinine Kinase Levels | Baseline and Day 3, 7, 11, 14, 17 | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles). | IU/L | MEAN |
| SECONDARY | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | 10^9 cells/liter | MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group293
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Participants Undergoing CAPD | GSK1278863; Day 1; n=1, 7 | 184.9863 | Geometric Coefficient of Variation NA | Hour into nanograms per milliliter |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Participants Undergoing APD | GSK1278863; Day 1; n=1, 7 | 138.6511 | Geometric Coefficient of Variation 93.5 | Hour into nanograms per milliliter |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Participants Undergoing CAPD | GSK1278863; Day 14; n=1, 4 | 162.9366 | Geometric Coefficient of Variation NA | Hour into nanograms per milliliter |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Participants Undergoing APD | GSK1278863; Day 14; n=1, 4 | 131.2826 | Geometric Coefficient of Variation 78.8 | Hour into nanograms per milliliter |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Participants Undergoing CAPD | GSK2391220; Day 1; n=1, 7 | 245.8999 | Geometric Coefficient of Variation NA | Hour into nanograms per milliliter |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Participants Undergoing APD | GSK2391220; Day 1; n=1, 7 | 147.8039 | Geometric Coefficient of Variation 47.7 | Hour into nanograms per milliliter |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Participants Undergoing CAPD | GSK2391220; Day 14; n=1, 4 | 258.1199 | Geometric Coefficient of Variation NA | Hour into nanograms per milliliter |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Participants Undergoing APD | GSK2391220; Day 14; n=1, 4 | 162.0324 | Geometric Coefficient of Variation 50.7 | Hour into nanograms per milliliter |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Participants Undergoing CAPD | GSK2487818; Day 1; n=1, 7 | 116.2608 | Geometric Coefficient of Variation NA | Hour into nanograms per milliliter |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Participants Undergoing APD | GSK2487818; Day 1; n=1, 7 | 67.4130 | Geometric Coefficient of Variation 39.1 | Hour into nanograms per milliliter |
1 to 10 of 293Source ClinicalTrials.gov
See all 293 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants Undergoing CAPD | 1 | |
| Overall Study | STARTED | Participants Undergoing APD | 7 | |
| Overall Study | COMPLETED | Participants Undergoing CAPD | 1 | |
| Overall Study | COMPLETED | Participants Undergoing APD | 4 | |
| Overall Study | NOT COMPLETED | Participants Undergoing CAPD | 0 | |
| Overall Study | NOT COMPLETED | Participants Undergoing APD | 3 |
Source ClinicalTrials.gov
Adverse events24
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 | Diarrhoea | Gastrointestinal disorders | Participants Undergoing CAPD | 1 | 1 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Participants Undergoing APD | 1 | 7 | 1 |
| other | Nausea | Gastrointestinal disorders | Participants Undergoing CAPD | 0 | 1 | 0 |
| other | Nausea | Gastrointestinal disorders | Participants Undergoing APD | 1 | 7 | 1 |
| other | Vomiting | Gastrointestinal disorders | Participants Undergoing CAPD | 0 | 1 | 0 |
| other | Vomiting | Gastrointestinal disorders | Participants Undergoing APD | 1 | 7 | 1 |
| other | Face oedema | General disorders | Participants Undergoing CAPD | 0 | 1 | 0 |
| other | Face oedema | General disorders | Participants Undergoing APD | 1 | 7 | 1 |
| other | Fatigue | General disorders | Participants Undergoing CAPD | 0 | 1 | 0 |
| other | Fatigue | General disorders | Participants Undergoing APD | 1 | 7 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants Undergoing CAPD | 0 | 1 |
| Total, all-cause mortality | Participants Undergoing APD | 0 | 7 |
| Total, other adverse events | Participants Undergoing CAPD | 1 | 1 |
| Total, other adverse events | Participants Undergoing APD | 5 | 7 |
| Total, serious adverse events | Participants Undergoing CAPD | 0 | 1 |
| Total, serious adverse events | Participants Undergoing APD | 0 | 7 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31583094 | BACKGROUND |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Participants Undergoing CAPD vs Participants Undergoing APD: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Trial comparisons |
| Participants Undergoing CAPD vs Participants Undergoing APD: deaths from any cause | Trial comparisons |
| Participants Undergoing CAPD vs Participants Undergoing APD: serious adverse events | 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/NCT02243306
GET https://conductscience.org/api/trials/v1/NCT02243306/registered?page=2