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NCT00130208 · ClinicalTrials.gov registry record · Phase 3

Effect of Sulodexide in Early Diabetic Nephropathy

A Phase 3 study, sponsored by Keryx Biopharmaceuticals.

Completed
Registry status
Phase 3
Development phase
1,056
Enrollment target

NCT00130208: Completed Phase 3 study, sponsored by Keryx Biopharmaceuticals.

NCT00130208 is a Phase 3 study that has completed, run by Keryx Biopharmaceuticals. The registered enrollment target is 1,056 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00130208, a Phase 3 study, has completed, sponsored by Keryx Biopharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
1,056 participants
Enrollment target

Study Summary

The purpose of the study is to determine whether treatment with sulodexide is effective in reducing the level of urine albumin excretion in patients with early diabetic kidney disease expressed as microalbuminuria.

Primary Outcome

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

Interventions

  • DRUG Placebo
  • DRUG Sulodexide

Trial Details

FieldValue
Enrollment Target 1,056 participants
Start Date 2005-08
Est. Completion 2008-02
Phase Phase 3
Keryx Biopharmaceuticals

9 total trials

What the finished NCT00130208 record still lists

NCT00130208 is an interventional study that assigns participants to a tested intervention. Its 1,056 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00130208 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00130208 about?

NCT00130208 is a clinical study titled "Effect of Sulodexide in Early Diabetic Nephropathy". The purpose of the study is to determine whether treatment with sulodexide is effective in reducing the level of urine albumin excretion in patients with early diabetic kidney disease expressed as microalbuminuria.

What is the current status of trial NCT00130208?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,056 participants. The study started on 2005-08. Estimated completion is 2008-02.

What interventions are being tested in trial NCT00130208?

The interventions under investigation include: Placebo (DRUG), Sulodexide (DRUG).

Who is sponsoring clinical trial NCT00130208?

This trial is sponsored by Keryx Biopharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00130208's enrollment target sits among peer trials

1,056 277th of 2000 higher than 1,724 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00130208, the US trial registry maintained by the National Library of Medicine. NCT00130208 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.