Trial · NCT01356966
Exercise Intolerance in Renal Failure
NCT01356966, Phase 2, Completed, Emory University; results first posted 2015-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exercise Intolerance in Renal Failure. Trials, record NCT01356966. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01356966
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exercise Intolerance in Renal Failure
- NCT number
- NCT01356966
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Kidney Failure, Chronic
- Interventions
- Tetrahydrobiopterin, Placebo, Folate
- First posted
- 2011-05-20
- Last updated
- 2015-06-01
- Results first posted
- 2015-06-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Resting Muscle Sympathetic Nerve Activity (MSNA) | Baseline, 12 weeks | |
| Secondary | Change in Mean Central Augmentation Index (AIx) | Baseline, 12 weeks | The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks. |
| Secondary | Change in Heart-rate-corrected Augmentation Index (AIx) | Baseline, 12 weeks | The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows: HR-corrected AIx = -0.39 x (75 - HR) + AIx. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks. |
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| PRIMARY | Change in Resting Muscle Sympathetic Nerve Activity (MSNA) | Baseline, 12 weeks | Two subjects withdrawn from each arm due to adverse events. Additionally, two subjects from the treatment group and one subject from the placebo group were not included in this analysis because an adequate MSNA neurogram was unable to be obtained at the end of the study. | bursts/minute | MEAN |
| SECONDARY | Change in Mean Central Augmentation Index (AIx) | Baseline, 12 weeks | percent | MEAN | |
| SECONDARY | Change in Heart-rate-corrected Augmentation Index (AIx) | Baseline, 12 weeks | percent | MEAN |
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 |
|---|---|---|---|---|---|
| Change in Resting Muscle Sympathetic Nerve Activity (MSNA) | Tetrahydrobiopterin + Folate | -7.5 | Standard Error 2.1 | bursts/minute | |
| Change in Resting Muscle Sympathetic Nerve Activity (MSNA) | Placebo + Folate | 3.2 | Standard Error 1.3 | bursts/minute | |
| Change in Mean Central Augmentation Index (AIx) | Tetrahydrobiopterin + Folate | -5.8 | Standard Error 2.0 | percent | |
| Change in Mean Central Augmentation Index (AIx) | Placebo + Folate | 1.8 | Standard Error 1.7 | percent | |
| Change in Heart-rate-corrected Augmentation Index (AIx) | Tetrahydrobiopterin + Folate | -3.2 | Standard Error 2.1 | percent | |
| Change in Heart-rate-corrected Augmentation Index (AIx) | Placebo + Folate | 1.1 | Standard Error 1.2 | percent |
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 | Tetrahydrobiopterin + Folate | 18 | |
| Overall Study | STARTED | Placebo + Folate | 14 | |
| Overall Study | COMPLETED | Tetrahydrobiopterin + Folate | 16 | |
| Overall Study | COMPLETED | Placebo + Folate | 12 | |
| Overall Study | NOT COMPLETED | Tetrahydrobiopterin + Folate | 2 | |
| Overall Study | NOT COMPLETED | Placebo + Folate | 2 |
Source ClinicalTrials.gov
Adverse events8
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 | Nausea | Gastrointestinal disorders | Tetrahydrobiopterin + Folate | 1 | 18 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo + Folate | 0 | 14 | 0 |
| other | Dysgeusia | General disorders | Tetrahydrobiopterin + Folate | 0 | 18 | 0 |
| other | Dysgeusia | General disorders | Placebo + Folate | 1 | 14 | 1 |
| other | Acute Kidney Injury | Renal and urinary disorders | Tetrahydrobiopterin + Folate | 1 | 18 | 1 |
| other | Acute Kidney Injury | Renal and urinary disorders | Placebo + Folate | 0 | 14 | 0 |
| other | Eye injury | Injury, poisoning and procedural complications | Tetrahydrobiopterin + Folate | 0 | 18 | 0 |
| other | Eye injury | Injury, poisoning and procedural complications | Placebo + Folate | 1 | 14 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tetrahydrobiopterin + Folate | ||
| Total, all-cause mortality | Placebo + Folate | ||
| Total, other adverse events | Tetrahydrobiopterin + Folate | 2 | 18 |
| Total, other adverse events | Placebo + Folate | 2 | 14 |
| Total, serious adverse events | Tetrahydrobiopterin + Folate | 0 | 18 |
| Total, serious adverse events | Placebo + Folate | 0 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26962106 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K23HL098744 | Neurovascular Dysfunction and Oxidative Stress in Renal Failure | PARK, JEANIE | EMORY UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2010 to 2014 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tetrahydrobiopterin + Folate vs Placebo + Folate: 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/NCT01356966
GET https://conductscience.org/api/trials/v1/NCT01356966/registered