Trial · NCT01491919
Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant
NCT01491919, Phase 1, Completed, Uptal Patel; results first posted 2015-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant. Trials, record NCT01491919. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01491919
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant
- NCT number
- NCT01491919
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- Uptal Patel
- Conditions
- Hypertension
- Interventions
- Lisinopril
- First posted
- 2011-12-14
- Last updated
- 2015-07-08
- Results first posted
- 2015-07-08
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics (PK) - Area Under the Plasma Concentration-time Curve (AUC) | Day 14 (+/- 3 days) of lisinopril therapy at hours 0 (pre-dose) and 1,2,4,5,8,12 and 24 hrs after dose | At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of AUC. Geometric mean was calculated from all measurements. |
| Primary | PK - Maximum Observed Concentration of Drug in Plasma (Cmax) | Day14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose | At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of Cmax. Geometric mean was calculated from all measurements. |
| Primary | PK - Time of the Maximum Observed Concentration in Plasma (Tmax) | Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose | At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of plasma lisinopril concentration. Medium was calculated from all measurements. |
| Primary | PK - Oral Clearance (CL/F) | Day 14 (+/- 3 d) of dose at 0 hour and at 1, 2, 4, 5, 8, 12, and 24 hrs after dose | At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CL/F. Geometric mean was calculated from all measurements. |
| Primary | PK Renal Clearance (CLrenal) | Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose. | At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CLrenal. Geometric mean was calculated from all measurements. |
| Primary | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) During/After Study Drug Administration | First dose of study drug to 30 days after final study visit for AEs and until resolution for SAEs | Number of Adverse Events (AEs) related and not related to study drug; number of Serious Adverse Events (SAEs) related and not related to study drug |
| Secondary | Change in Potassium Level From Baseline in Lisinopril-naive Participants | At baseline visit and Day 14 prior to final study dose. | Potassium values will be obtained at Baseline and Day 14 prior to the final dose of study drug. Mean calculated from the two measurements. |
| Secondary | Worse Post-dose Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline in Lisinopril-naive Participants | Baseline to Day 14 (+/- 3 days) | The eGFR at entry will need to be ≥ 30 ml/min/1.73m\^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitors (ACE-I)-mediated reduction in kidney function. eGFR ratio was computed from the worst post-dose value divided by the Baseline value. |
| Secondary | Largest eGFR Percent Decrease From Baseline in Lisinopril-naive Participants | Baseline to Day 14 (+/- 3 days) | The eGFR at entry will need to be ≥ 30 ml/min/1.73m\^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitor (ACEI) mediated reduction in kidney function. Largest eGFR percent decrease from baseline reported in results section. |
| Secondary | Change in Urine Protein/Creatinine From Baseline in Lisinopril-naive Participants. | Baseline to worst post-dose before Day 14 (+/- 3 days) | Change in urine protein/creatinine obtained as follows: Mean change (worst post-dose from baseline) presented for urine protein/creatinine ratio. Geometric mean of the ratio (worst post-dose / baseline with Geometric Coefficient of Variation percent (CV%) and greatest decrease presented for eGFR by dose group. Two patients in the high dose group had an evaluable urine protein/creatinine change. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacokinetics (PK) - Area Under the Plasma Concentration-time Curve (AUC) | Day 14 (+/- 3 days) of lisinopril therapy at hours 0 (pre-dose) and 1,2,4,5,8,12 and 24 hrs after dose | ng*h/mL | GEOMETRIC_MEAN | |
| PRIMARY | PK - Maximum Observed Concentration of Drug in Plasma (Cmax) | Day14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose | ng/ml | GEOMETRIC_MEAN | |
| SECONDARY | Change in Potassium Level From Baseline in Lisinopril-naive Participants | At baseline visit and Day 14 prior to final study dose. | mEq/L | MEAN | |
| SECONDARY | Worse Post-dose Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline in Lisinopril-naive Participants | Baseline to Day 14 (+/- 3 days) | ratio | GEOMETRIC_MEAN | |
| PRIMARY | PK - Time of the Maximum Observed Concentration in Plasma (Tmax) | Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose | hours | MEDIAN | |
| PRIMARY | PK - Oral Clearance (CL/F) | Day 14 (+/- 3 d) of dose at 0 hour and at 1, 2, 4, 5, 8, 12, and 24 hrs after dose | L/h/70 kg | GEOMETRIC_MEAN | |
| PRIMARY | PK Renal Clearance (CLrenal) | Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose. | L/h/70 kg | GEOMETRIC_MEAN | |
| PRIMARY | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) During/After Study Drug Administration | First dose of study drug to 30 days after final study visit for AEs and until resolution for SAEs | events | NUMBER | |
| SECONDARY | Largest eGFR Percent Decrease From Baseline in Lisinopril-naive Participants | Baseline to Day 14 (+/- 3 days) | percentage | NUMBER | |
| SECONDARY | Change in Urine Protein/Creatinine From Baseline in Lisinopril-naive Participants. | Baseline to worst post-dose before Day 14 (+/- 3 days) | mg/mg | GEOMETRIC_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pharmacokinetics (PK) - Area Under the Plasma Concentration-time Curve (AUC) | Low Dose: Lisinopril | 298 | Geometric Coefficient of Variation 46.5 | ng*h/mL | |
| Pharmacokinetics (PK) - Area Under the Plasma Concentration-time Curve (AUC) | Medium Dose: Lisinopril | 640 | Geometric Coefficient of Variation 28.6 | ng*h/mL | |
| Pharmacokinetics (PK) - Area Under the Plasma Concentration-time Curve (AUC) | High Dose: Lisinopril | 702 | Geometric Coefficient of Variation 66.4 | ng*h/mL | |
| PK - Maximum Observed Concentration of Drug in Plasma (Cmax) | Low Dose: Lisinopril | 20.9 | Geometric Coefficient of Variation 41.2 | ng/ml | |
| PK - Maximum Observed Concentration of Drug in Plasma (Cmax) | Medium Dose: Lisinopril | 47.7 | Geometric Coefficient of Variation 25.1 | ng/ml | |
| PK - Maximum Observed Concentration of Drug in Plasma (Cmax) | High Dose: Lisinopril | 58.0 | Geometric Coefficient of Variation 41.2 | ng/ml | |
| Change in Potassium Level From Baseline in Lisinopril-naive Participants | Low Dose: Lisinopril | 0.1 | Standard Deviation 0.3 | mEq/L | |
| Change in Potassium Level From Baseline in Lisinopril-naive Participants | Medium Dose: Lisinopril | -0.3 | Standard Deviation 0.6 | mEq/L | |
| Change in Potassium Level From Baseline in Lisinopril-naive Participants | High Dose: Lisinopril | 0.3 | Standard Deviation 0.5 | mEq/L | |
| Worse Post-dose Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline in Lisinopril-naive Participants | Low Dose: Lisinopril | 1 | Geometric Coefficient of Variation 14 | ratio |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Dose: Lisinopril | 13 | |
| Overall Study | STARTED | Medium Dose: Lisinopril | 10 | |
| Overall Study | STARTED | High Dose: Lisinopril | 3 | |
| Overall Study | COMPLETED | Low Dose: Lisinopril | 12 | |
| Overall Study | COMPLETED | Medium Dose: Lisinopril | 8 | |
| Overall Study | COMPLETED | High Dose: Lisinopril | 2 | |
| Overall Study | NOT COMPLETED | Low Dose: Lisinopril | 1 | |
| Overall Study | NOT COMPLETED | Medium Dose: Lisinopril | 2 | |
| Overall Study | NOT COMPLETED | High Dose: Lisinopril | 1 |
Source ClinicalTrials.gov
Adverse events51
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 | Anaemia | Blood and lymphatic system disorders | Low Dose: Lisinopril | 1 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Medium Dose: Lisinopril | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | High Dose: Lisinopril | 0 | 2 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Low Dose: Lisinopril | 1 | 12 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Medium Dose: Lisinopril | 2 | 8 | |
| other | Abdominal pain upper | Gastrointestinal disorders | High Dose: Lisinopril | 0 | 2 | |
| other | Diarrhea | Gastrointestinal disorders | Low Dose: Lisinopril | 0 | 12 | |
| other | Diarrhea | Gastrointestinal disorders | Medium Dose: Lisinopril | 2 | 8 | |
| other | Diarrhea | Gastrointestinal disorders | High Dose: Lisinopril | 0 | 2 | |
| other | Nausea | Gastrointestinal disorders | Low Dose: Lisinopril | 1 | 12 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose: Lisinopril | ||
| Total, all-cause mortality | Medium Dose: Lisinopril | ||
| Total, all-cause mortality | High Dose: Lisinopril | ||
| Total, other adverse events | Low Dose: Lisinopril | 5 | 12 |
| Total, other adverse events | Medium Dose: Lisinopril | 4 | 8 |
| Total, other adverse events | High Dose: Lisinopril | 2 | 2 |
| Total, serious adverse events | Low Dose: Lisinopril | 0 | 12 |
| Total, serious adverse events | Medium Dose: Lisinopril | 1 | 8 |
| Total, serious adverse events | High Dose: Lisinopril | 0 | 2 |
Source ClinicalTrials.gov
Papers32
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01491919
GET https://conductscience.org/api/trials/v1/NCT01491919/results?page=2