Trial · NCT00065611
Steroid Treatment for Kidney Disease
NCT00065611, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2011-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Steroid Treatment for Kidney Disease. Trials, record NCT00065611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00065611
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Steroid Treatment for Kidney Disease
- NCT number
- NCT00065611
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 8 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Nephrosis, Focal Lipoid Glomerulosclerosis
- Interventions
- Oral dexamethasone
- First posted
- 2003-07-29
- Last updated
- 2011-10-28
- Results first posted
- 2011-10-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks | 48 weeks from baseline | Complete remission is defined as proteinuria \<0.3 g/d. Partial remission is defined as a 50% fall in proteinuria compared to baseline, proteinuria \<3.5 g/d, and a preserved estimated glomerular filtration rate (eGFR), specified as \>60% of baseline. Limited response is defined as a 50% fall in proteinuria compared to baseline. All other outcomes are described as non-response. |
| Secondary | Urine Protein | 48 weeks from baseline | |
| Secondary | CKD-EPI eGFR | 48 weeks from baseline | Estimate glomerular filtration rate (eGFR) using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula. |
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 | Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks | 48 weeks from baseline | ITT | participants | NUMBER |
| SECONDARY | Urine Protein | 48 weeks from baseline | g/d | MEAN | |
| SECONDARY | CKD-EPI eGFR | 48 weeks from baseline | ml/min/1.73m^2 | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks | 2 Doses Every 2 Weeks Arm | Limited response | 1 | participants | |
| Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks | 4 Doses Every 4 Weeks Arm | Limited response | 1 | participants | |
| Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks | 2 Doses Every 2 Weeks Arm | Non-response | 2 | participants | |
| Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks | 4 Doses Every 4 Weeks Arm | Non-response | 1 | participants | |
| Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks | 2 Doses Every 2 Weeks Arm | Partial remission | 1 | participants | |
| Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks | 4 Doses Every 4 Weeks Arm | Partial remission | 1 | participants | |
| Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks | 2 Doses Every 2 Weeks Arm | Complete remission | 0 | participants | |
| Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks | 4 Doses Every 4 Weeks Arm | Complete remission | 0 | participants | |
| Urine Protein | 2 Doses Every 2 Weeks Arm | 3.6 | Standard Deviation 0.7 | g/d | |
| Urine Protein | 4 Doses Every 4 Weeks Arm | 6.2 | Standard Deviation 4.8 | g/d |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 2 Doses Every 2 Weeks Arm | 4 | |
| Overall Study | STARTED | 4 Doses Every 4 Weeks Arm | 4 | |
| Overall Study | COMPLETED | 2 Doses Every 2 Weeks Arm | 4 | |
| Overall Study | COMPLETED | 4 Doses Every 4 Weeks Arm | 3 | |
| Overall Study | NOT COMPLETED | 2 Doses Every 2 Weeks Arm | 0 | |
| Overall Study | NOT COMPLETED | 4 Doses Every 4 Weeks Arm | 1 |
Source ClinicalTrials.gov
Adverse events22
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 | Headache | General disorders | 2 Doses Every 2 Weeks Arm | 1 | 4 | 1 |
| other | Headache | General disorders | 4 Doses Every 4 Weeks Arm | 0 | 4 | 0 |
| other | sleep disturbance | General disorders | 2 Doses Every 2 Weeks Arm | 1 | 4 | 1 |
| other | sleep disturbance | General disorders | 4 Doses Every 4 Weeks Arm | 1 | 4 | 1 |
| other | Mood swings | General disorders | 2 Doses Every 2 Weeks Arm | 2 | 4 | 2 |
| other | Mood swings | General disorders | 4 Doses Every 4 Weeks Arm | 1 | 4 | 1 |
| other | Change in appetite | General disorders | 2 Doses Every 2 Weeks Arm | 0 | 4 | 0 |
| other | Change in appetite | General disorders | 4 Doses Every 4 Weeks Arm | 1 | 4 | 1 |
| other | Weight gain | General disorders | 2 Doses Every 2 Weeks Arm | 0 | 4 | 0 |
| other | Weight gain | General disorders | 4 Doses Every 4 Weeks Arm | 1 | 4 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 2 Doses Every 2 Weeks Arm | ||
| Total, all-cause mortality | 4 Doses Every 4 Weeks Arm | ||
| Total, other adverse events | 2 Doses Every 2 Weeks Arm | 3 | 4 |
| Total, other adverse events | 4 Doses Every 4 Weeks Arm | 1 | 4 |
| Total, serious adverse events | 2 Doses Every 2 Weeks Arm | 1 | 4 |
| Total, serious adverse events | 4 Doses Every 4 Weeks Arm | 2 | 4 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 2 Doses Every 2 Weeks Arm vs 4 Doses Every 4 Weeks Arm: 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/NCT00065611
GET https://conductscience.org/api/trials/v1/NCT00065611/events?page=2