Type 1 DiabetesPhase 4MIKALNCT02829177
Microalbuminuria and Allopurinol in Type 1 Diabetes
A Phase 4 study testing Allopurinol in people with Type 1 Diabetes and Diabetic Nephropathy, run by Peter Rossing at 1 site in Denmark.
Trial summary
The objective is to determine if lowering serum uric acid by means of allopurinol in the course of kidney disease may be effective in preventing or improving albuminuria and renal function in Type 1 Diabetic patients. The study is a double blinded, randomised, placebo-controlled cross-over clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes, Diabetic Nephropathy
- What is being tested?
- Allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to 20 Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Albuminuria (≥30 mg/g)
- Uric Acid ≥ 0,265 mmol/l
- GFR (glomerular filtration rate) > 40 ml/min/1.73m2
Who cannot join
- History of gout or xanthinuria or other indications for uric acid lowering therapy such as cancer chemotherapy.
- Recurrent renal calculi.
- Current use of azathioprine, 6-mercaptopurine, didanosine, tamoxifen, amoxicillin/ampicillin, or other drugs interacting with allopurinol.
- Known allergy to xanthine-oxidase inhibitors.
- Renal transplant.
- Non-diabetic kidney disease.
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- Home, 24h og clinical BP>180 or Diastolic BP >130 mmHg at screening.
- Cancer treatment within two years before screening.
- History of hepatitis B or C.
- History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection.
- History of alcohol or drug abuse.
- Breastfeeding or pregnancy or unwillingness to be on contraception throughout the trial.
- Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study.
- Serious pre-existing medical problems other than diabetes, e.g. congestive heart failure, pulmonary insufficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo Controlled Trial of Allopurinol in Patients With Type 1 Diabetes and Microalbuminuria
The objective is to determine if lowering serum uric acid by means of allopurinol in the course of kidney disease may be effective in preventing or improving albuminuria and renal function in Type 1 Diabetic patients. The study is a double blinded, randomised, placebo-controlled cross-over clinical trial.
- Conditions
- Type 1 Diabetes, Diabetic Nephropathy
- Being tested
- Allopurinol, Placebo
- Keywords
- Type 1 diabetes, Diabetic nephropathy, Albuminuria, Allopurinol
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Nephropathies, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Active comparator | 400 mg once daily, tablet treatment Receives: Drug: Allopurinol |
| Placebo | Placebo comparator | Identical tablet treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Albuminuria
Improvement of albuminuria will be evaluated by the collection of 24h urin collection with the measure of 24h albumine excretion rate and the measurements will be compared for the two treatment arm for each participant.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startSep 2014
- Primary completion10 Aug 2016
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Rossing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Rossing, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829177
- Sponsor's protocol ID
- 3004
- Acronym
- MIKAL
- Status last verified
- Sep 2018
- First submitted
- 27 Mar 2015
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo Controlled Trial of Allopurinol in Patients With Type 1 Diabetes and Microalbuminuria
- ClinicalTrials.gov ID
- NCT02829177
- Acronym / sponsor ID
- MIKAL / 3004
- Conditions
- Type 1 Diabetes, Diabetic Nephropathy
- Keywords
- Type 1 diabetes, Diabetic nephropathy, Albuminuria, Allopurinol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peter RossingUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 10 Aug 2016 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to determine if lowering serum uric acid by means of allopurinol in the course of kidney disease may be effective in preventing or improving albuminuria and renal function in Type 1 Diabetic patients. The study is a double blinded, randomised, placebo-controlled cross-over clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Active comparator | Drug: Allopurinol400 mg once daily, tablet treatment |
| Placebo | Placebo comparator | Drug: PlaceboIdentical tablet treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Albuminuria (≥30 mg/g)
- Uric Acid ≥ 0,265 mmol/l
- GFR (glomerular filtration rate) > 40 ml/min/1.73m2
Key exclusion criteria (14 listed)
- History of gout or xanthinuria or other indications for uric acid lowering therapy such as cancer chemotherapy.
- Recurrent renal calculi.
- Current use of azathioprine, 6-mercaptopurine, didanosine, tamoxifen, amoxicillin/ampicillin, or other drugs interacting with allopurinol.
- Known allergy to xanthine-oxidase inhibitors.
- Renal transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allopurinol | Drug | Allopurinol |
| Placebo | Drug | Placebo |
Primary outcome
Improved Albuminuria
Time frame: 60 days
Improvement of albuminuria will be evaluated by the collection of 24h urin collection with the measure of 24h albumine excretion rate and the measurements will be compared for the two treatment arm for each participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allopurinol in people with Type 1 Diabetes and Diabetic Nephropathy, run by Peter Rossing at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved Albuminuria (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.