Trial · NCT00625820
Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria
NCT00625820, Phase 2, Completed, University of Michigan; results first posted 2016-10-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria. Trials, record NCT00625820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00625820
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria
- NCT number
- NCT00625820
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Kidney Disease, Albuminuria
- Interventions
- 6R BH4, Vitamin C
- First posted
- 2008-02-28
- Last updated
- 2016-10-18
- Results first posted
- 2016-10-18
- Limitations and caveats
- It was a small single center non-randomized pilot study \& was not powered to detect significant changes in albuminuria.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Outcome Measure is Level of Albuminuria. | 12 weeks | Early morning urine specimens were collected to calculate albumin and creatinine ratio (albuminuria) at 6 and 12 weeks of therapy. |
| Secondary | Systolic Blood Pressure Measured at 6 and 12 Weeks of Therapy. | 12 weeks | |
| Secondary | Estimated Glomerular Filtration Rate (eGFR) Measured at 6 and 12 Weeks of Therapy. | 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 | The Primary Outcome Measure is Level of Albuminuria. | 12 weeks | All participants who finished the trial were analyzed | ratio | MEAN |
| SECONDARY | Systolic Blood Pressure Measured at 6 and 12 Weeks of Therapy. | 12 weeks | mmHG | MEAN | |
| SECONDARY | Estimated Glomerular Filtration Rate (eGFR) Measured at 6 and 12 Weeks of Therapy. | 12 weeks | ml/min/1.73m2 | 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 |
|---|---|---|---|---|---|
| The Primary Outcome Measure is Level of Albuminuria. | 1BH4, BH4 + Vitamin C | Albuminuria at week 6 | 927.9 | Standard Deviation 244.9 | ratio |
| The Primary Outcome Measure is Level of Albuminuria. | 1BH4, BH4 + Vitamin C | Albuminuria at week 12 | 897.1 | Standard Deviation 217.9 | ratio |
| Systolic Blood Pressure Measured at 6 and 12 Weeks of Therapy. | 1BH4, BH4 + Vitamin C | Systolic Blood Pressure at week 6 | 143.1 | Standard Deviation 5.1 | mmHG |
| Systolic Blood Pressure Measured at 6 and 12 Weeks of Therapy. | 1BH4, BH4 + Vitamin C | Systolic Blood Pressure at week 12 | 134.1 | Standard Deviation 3.71 | mmHG |
| Estimated Glomerular Filtration Rate (eGFR) Measured at 6 and 12 Weeks of Therapy. | 1BH4, BH4 + Vitamin C | eGFR at week 6 | 68.1 | Standard Deviation 6.7 | ml/min/1.73m2 |
| Estimated Glomerular Filtration Rate (eGFR) Measured at 6 and 12 Weeks of Therapy. | 1BH4, BH4 + Vitamin C | eGFR at week 12 | 70.8 | Standard Deviation 6.4 | ml/min/1.73m2 |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1BH4, BH4 + Vitamin C | 17 | |
| Overall Study | COMPLETED | 1BH4, BH4 + Vitamin C | 16 | |
| Overall Study | NOT COMPLETED | 1BH4, BH4 + Vitamin C | 1 |
Source ClinicalTrials.gov
Adverse events1
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 | Nephrolithiasis | Renal and urinary disorders | BH4, BH4 + Vit C | 1 | 17 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BH4, BH4 + Vit C | ||
| Total, other adverse events | BH4, BH4 + Vit C | 1 | 17 |
| Total, serious adverse events | BH4, BH4 + Vit C | 0 | 17 |
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 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/NCT00625820
GET https://conductscience.org/api/trials/v1/NCT00625820/registered