Trial · NCT00130208
Effect of Sulodexide in Early Diabetic Nephropathy
NCT00130208, Phase 3, Completed, Keryx Biopharmaceuticals; results first posted 2018-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Sulodexide in Early Diabetic Nephropathy. Trials, record NCT00130208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00130208
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Sulodexide in Early Diabetic Nephropathy
- NCT number
- NCT00130208
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,056 participants, actual
- Lead sponsor
- Keryx Biopharmaceuticals
- Conditions
- Diabetic Nephropathy
- Interventions
- Sulodexide, Placebo
- First posted
- 2005-08-15
- Last updated
- 2018-03-23
- Results first posted
- 2018-03-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Conversion From Microalbuminuria to Normoalbuminuria | 26 Weeks | The primary efficacy variable was the fraction of those patients in the ITT population with valid baseline and Week 26 ACRs in whom "therapeutic success" was achieved at Week 26 measured as a conversion of microalbuminuria to normoalbuminuria and at least a 25% reduction in ACR relative to baseline |
| Primary | Number of Subjects With Greater Than 50% Reduction in Microalbuminuria | 26 Weeks | During the treatment period, KRX-101 is being compared to placebo to assess whether a 50% reduction in microalbuminuria has been achieved. |
| Secondary | Change in Serum Albumin From Baseline to End of 26 Weeks | 26 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 | Number of Subjects With Conversion From Microalbuminuria to Normoalbuminuria | 26 Weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Subjects With Greater Than 50% Reduction in Microalbuminuria | 26 Weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Serum Albumin From Baseline to End of 26 Weeks | 26 Weeks | Participant numbers include those with both baseline and week 26 measurements | percent change | LEAST_SQUARES_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 |
|---|---|---|---|---|---|
| Number of Subjects With Conversion From Microalbuminuria to Normoalbuminuria | Sulodexide | 39 | Participants | ||
| Number of Subjects With Conversion From Microalbuminuria to Normoalbuminuria | Placebo | 30 | Participants | ||
| Number of Subjects With Greater Than 50% Reduction in Microalbuminuria | Sulodexide | 76 | Participants | ||
| Number of Subjects With Greater Than 50% Reduction in Microalbuminuria | Placebo | 87 | Participants | ||
| Change in Serum Albumin From Baseline to End of 26 Weeks | Sulodexide | -0.02 | Standard Error 0.01 | percent change | |
| Change in Serum Albumin From Baseline to End of 26 Weeks | Placebo | -0.02 | Standard Error 0.01 | percent change |
Source ClinicalTrials.gov
Participant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Maintenance Period (26 Weeks) | STARTED | Sulodexide | 524 | |
| Maintenance Period (26 Weeks) | STARTED | Placebo | 532 | |
| Maintenance Period (26 Weeks) | Valid Albumin Creatinine Ratio | Sulodexide | 492 | |
| Maintenance Period (26 Weeks) | Valid Albumin Creatinine Ratio | Placebo | 494 | |
| Maintenance Period (26 Weeks) | COMPLETED | Sulodexide | 500 | |
| Maintenance Period (26 Weeks) | COMPLETED | Placebo | 502 | |
| Maintenance Period (26 Weeks) | NOT COMPLETED | Sulodexide | 24 | |
| Maintenance Period (26 Weeks) | NOT COMPLETED | Placebo | 30 | |
| Washout Period (8 Weeks) | STARTED | Sulodexide | 500 | |
| Washout Period (8 Weeks) | STARTED | Placebo | 502 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events174
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 | Coronary Artery Disease | Cardiac disorders | Sulodexide | 6 | 523 | |
| other | Coronary Artery Disease | Cardiac disorders | Placebo | 3 | 532 | |
| other | Diarrhea | Gastrointestinal disorders | Sulodexide | 21 | 523 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 20 | 532 | |
| other | Constipation | Gastrointestinal disorders | Sulodexide | 10 | 523 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 11 | 532 | |
| other | Nausea | Gastrointestinal disorders | Sulodexide | 10 | 523 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 532 | |
| other | Abdominal Pain | Gastrointestinal disorders | Sulodexide | 4 | 523 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 6 | 532 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sulodexide | 2 | 523 |
| Total, all-cause mortality | Placebo | 3 | 532 |
| Total, other adverse events | Sulodexide | 348 | 523 |
| Total, other adverse events | Placebo | 358 | 532 |
| Total, serious adverse events | Sulodexide | 21 | 523 |
| Total, serious adverse events | Placebo | 33 | 532 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21872376 | DERIVED |
Source PubMed
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sulodexide vs Placebo: Number of Subjects With Greater Than 50% Reduction in Microalbuminuria | Trial comparisons |
| Sulodexide vs Placebo: Number of Subjects With Conversion From Microalbuminuria to Normoalbuminuria | Trial comparisons |
| Sulodexide vs Placebo: deaths from any cause | Trial comparisons |
| Sulodexide vs Placebo: 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/NCT00130208
GET https://conductscience.org/api/trials/v1/NCT00130208/events?page=2