Trial · NCT01759862
Perioperative Aminophylline to Improve Early Kidney Function After a Kidney Transplant
NCT01759862, Not applicable, Completed, Stanford University; results first posted 2019-03-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Perioperative Aminophylline to Improve Early Kidney Function After a Kidney Transplant. Trials, record NCT01759862. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01759862
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perioperative Aminophylline to Improve Early Kidney Function After a Kidney Transplant
- NCT number
- NCT01759862
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 50 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Function of Renal Transplant
- Interventions
- Aminophylline, Theophylline drug levels, Placebo
- First posted
- 2013-01-03
- Last updated
- 2019-03-05
- Results first posted
- 2019-03-05
- Limitations and caveats
- Small sample size
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Calculated Estimated Glomerular Filtration Rate (eGFR) | 5 days | The investigators will measure blood creatinine on post-operative day 5 and using the Schwartz equation will calculate estimated glomerular filtration rate (GFR) to determine kidney function. |
| Secondary | Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)/ Creatinine Ratio | 12 hours post transplant | urinary NGAL(Neutrophil gelatinase-associated lipocalin) is a biomarker for kidney injury. NGAL levels 12h post-transplant were found to be a marker for development of delayed graft function and need for dialysis post-transplant. NGAL levels are corrected for urine creatinine. |
| Other | Presence of Fibrosis Measured on Protocol Biopsy | 6 months | The investigators will use the same cores that are obtained during routine 6 months protocol biopsies to quantify the amount of fibrosis |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Calculated Estimated Glomerular Filtration Rate (eGFR) | 5 days | Intention to treat analysis | ml/min/1.73m2 | MEAN |
| SECONDARY | Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)/ Creatinine Ratio | 12 hours post transplant | Participants with available data were included in the analysis. | ng/mg | MEDIAN |
| OTHER_PRE_SPECIFIED | Presence of Fibrosis Measured on Protocol Biopsy | 6 months | Participants with available data were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Calculated Estimated Glomerular Filtration Rate (eGFR) | Aminophylline | 67.39 | Standard Deviation 38.9 | ml/min/1.73m2 | |
| Calculated Estimated Glomerular Filtration Rate (eGFR) | Control | 80.48 | Standard Deviation 52.1 | ml/min/1.73m2 | |
| Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)/ Creatinine Ratio | Aminophylline | 300.5 | Inter-Quartile Range 105.5 to 1464.5 | ng/mg | |
| Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)/ Creatinine Ratio | Control | 425.4 | Inter-Quartile Range 140.3 to 1126.2 | ng/mg | |
| Presence of Fibrosis Measured on Protocol Biopsy | Aminophylline | 11 | Participants | ||
| Presence of Fibrosis Measured on Protocol Biopsy | Control | 14 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aminophylline | 23 | |
| Overall Study | STARTED | Control | 27 | |
| Overall Study | COMPLETED | Aminophylline | 20 | |
| Overall Study | COMPLETED | Control | 25 | |
| Overall Study | NOT COMPLETED | Aminophylline | 3 | |
| Overall Study | NOT COMPLETED | Control | 2 |
Source ClinicalTrials.gov
Adverse 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 | Agitation | Nervous system disorders | Aminophylline | 0 | 23 | |
| other | Agitation | Nervous system disorders | Control | 2 | 27 | |
| other | tachycardia at day 1 post transplant | Cardiac disorders | Aminophylline | 7 | 23 | |
| other | tachycardia at day 1 post transplant | Cardiac disorders | Control | 6 | 27 | |
| other | tacrolimus toxicity | Injury, poisoning and procedural complications | Aminophylline | 7 | 23 | |
| other | tacrolimus toxicity | Injury, poisoning and procedural complications | Control | 10 | 27 | |
| other | Acute kidney injury | Renal and urinary disorders | Aminophylline | 0 | 23 | |
| other | Acute kidney injury | Renal and urinary disorders | Control | 2 | 27 | |
| other | Rejection | Renal and urinary disorders | Aminophylline | 4 | 23 | |
| other | Rejection | Renal and urinary disorders | Control | 6 | 27 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aminophylline | 0 | 23 |
| Total, all-cause mortality | Control | 0 | 27 |
| Total, other adverse events | Aminophylline | 9 | 23 |
| Total, other adverse events | Control | 13 | 27 |
| Total, serious adverse events | Aminophylline | 0 | 23 |
| Total, serious adverse events | Control | 0 | 27 |
Source ClinicalTrials.gov
Papers4
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aminophylline vs Control: Presence of Fibrosis Measured on Protocol Biopsy | Trial comparisons |
| Aminophylline vs Control: deaths from any cause | Trial comparisons |
| Aminophylline vs Control: 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/NCT01759862
GET https://conductscience.org/api/trials/v1/NCT01759862/registered