Trial · NCT00001959
Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)
NCT00001959, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2012-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis). Trials, record NCT00001959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001959
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)
- NCT number
- NCT00001959
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Fibrosis, Focal Glomerulosclerosis, Kidney Failure, Nephrotic Syndrome, Proteinuria
- Interventions
- Pirfenidone
- First posted
- 2000-01-19
- Last updated
- 2014-05-26
- Results first posted
- 2012-06-01
- Limitations and caveats
- No control group, measurement imprecision, results may not applicable to all patients with FSGS, needs histologic evidence to support our findings, Optimal dosage needs to be identified.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Decrease in GFR During Treatment Period | 12 months from baseline | |
| Secondary | Proteinuria After Treatment | 12 months from baseline | |
| Secondary | Proportion of Patients With Positive Change in GFR | 12 months from baseline |
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 | Decrease in GFR During Treatment Period | 12 months from baseline | ITT | ml/min/1.73 m2 | MEAN |
| SECONDARY | Proteinuria After Treatment | 12 months from baseline | g/d | MEDIAN | |
| SECONDARY | Proportion of Patients With Positive Change in GFR | 12 months from baseline | participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Decrease in GFR During Treatment Period | Pirfenidone | -0.45 | Inter-Quartile Range -0.78 to -0.16 | ml/min/1.73 m2 | |
| Proteinuria After Treatment | Pirfenidone | 4.3 | Inter-Quartile Range 1.2 to 6.7 | g/d | |
| Proportion of Patients With Positive Change in GFR | Pirfenidone | 13 | participants |
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 | Pirfenidone | 21 | |
| Overall Study | COMPLETED | Pirfenidone | 18 | |
| Overall Study | NOT COMPLETED | Pirfenidone | 3 |
Source ClinicalTrials.gov
Adverse events6
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 | Gastrointestinal discomfort | Gastrointestinal disorders | Pirfenidone | 8 | 21 | 8 |
| other | Sedation or fatigue | General disorders | Pirfenidone | 6 | 21 | 6 |
| other | photosensitivity dermatitis | Skin and subcutaneous tissue disorders | Pirfenidone | 2 | 21 | 2 |
| serious | Death (unrelated to the trial) | Injury, poisoning and procedural complications | Pirfenidone | 1 | 21 | 1 |
| serious | Colon cancer (unrelated to the trial) | Gastrointestinal disorders | Pirfenidone | 1 | 21 | 1 |
| serious | elevated liver enzymes (judged possibly related to the trial) | Hepatobiliary disorders | Pirfenidone | 1 | 21 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pirfenidone | ||
| Total, other adverse events | Pirfenidone | 16 | 21 |
| Total, serious adverse events | Pirfenidone | 3 | 21 |
Source ClinicalTrials.gov
Papers3
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/NCT00001959
GET https://conductscience.org/api/trials/v1/NCT00001959/registered