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NCT02017171 · ClinicalTrials.gov registry record · Phase 3
A Multicenter Clinical Trial of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes
A Phase 3 study, sponsored by Alessandro Doria.
- Completed
- Registry status
- Phase 3
- Development phase
- 530
- Enrollment target
NCT02017171: Completed Phase 3 study, sponsored by Alessandro Doria.
NCT02017171 is a Phase 3 study that has completed, run by Alessandro Doria. The registered enrollment target is 530 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02017171, a Phase 3 study, has completed, sponsored by Alessandro Doria.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 530 participants
- Enrollment target
Study Summary
Despite improvements during the past 20 years in blood glucose and blood pressure control, diabetic kidney disease remains one of the most important causes of health problems in patients with diabetes. Novel treatments to complement blood glucose and blood pressure control are urgently needed. The goal of this study is to see whether a medication called allopurinol may help prevent loss of kidney function among people with type 1 diabetes. Allopurinol has been used for many years to decrease high blood uric acid and treat gout - a disease characterized by arthritis, especially of the foot joints. There is evidence suggesting that allopurinol might also be useful in people with diabetes who have normal or moderately impaired kidney function to decrease the risk of developing advanced kidney disease in the future. To prove this beneficial effect of allopurinol, we will be conducting an international clinical trial at eight diabetes centers, enrolling approximately 480 patients with type 1 diabetes who are at increased risk of developing kidney disease. Participants will be randomly assigned to take allopurinol or placebo (inactive pill) for three years, during which they will be followed through periodical visits. To prevent any possible bias, neither the participants nor the clinical staff knows who is taking allopurinol and who is taking the placebo. Kidney function will be measured at the beginning and at the end of the treatment period to see whether patients taking allopurinol experience a slower loss of kidney function over time as compared to those taking the inactive pill. If this trial is successful, the reduction in health problems resulting from the prevention or delay of kidney function loss due to the use of allopurinol would have a major impact on the lives of type 1 diabetic patients as well as on society at large, significantly reducing the human and financial costs associated with diabetic kidney disease. Because of the emphasis on early intervention,
Primary Outcome
Glomerular filtration rate (GFR) at the end of the 2-month wash-out period following the 3-year treatment period, measured by the plasma disappearance of non-radioactive iohexol (iGFR) and adjusted for the iGFR at baseline.
Interventions
- DRUG Placebo
- DRUG Allopurinol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2014-02 |
| Est. Completion | 2019-08-31 |
| Phase | Phase 3 |
What the finished NCT02017171 record still lists
NCT02017171 is an interventional study that assigns participants to a tested intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02017171 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02017171 about?
NCT02017171 is a clinical study titled "A Multicenter Clinical Trial of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes". Despite improvements during the past 20 years in blood glucose and blood pressure control, diabetic kidney disease remains one of the most important causes of health problems in patients with diabetes. Novel treatments to complement blood glucose and blood pressure control are urgently needed. The g...
What is the current status of trial NCT02017171?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2014-02. Estimated completion is 2019-08-31.
What interventions are being tested in trial NCT02017171?
The interventions under investigation include: Placebo (DRUG), Allopurinol (DRUG).
Who is sponsoring clinical trial NCT02017171?
This trial is sponsored by Alessandro Doria, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02017171's enrollment target sits among peer trials
530 706th of 2000 higher than 1,292 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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