MicroalbuminuriaCLINPRADIANCT01907958
Management of Albuminuria in Hypertensive Diabetics
An observational study of Microalbuminuria and Hypertension, run by Medpharmgene, Inc. at 1 site in Canada.
Trial summary
Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin to usual practice on quality of care in hypertensive patients with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microalbuminuria, Hypertension, Type 2 Diabetes
- How many people
- 280 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Jun 2014
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 years and older Uncontrolled blood pressure Type 2 diabetes
Who may be able to join
- Male or female 18 years and older and able to visit the study sites every 3 months
- T2D patients with ongoing anti-diabetic therapy for at least 5 years
- Uncontrolled hypertension according to 2012 CHEP recommendations for management of hypertension in diabetic patients ( i.e. BP> 130/80 mmHg)
- Able and agreeing to provide informed consent.
Who cannot join
- Type 1 diabetes patients
- Ongoing therapy with perindopril,
- Known hypersensitivity or allergies to ACEI or sulfonamide derivatives,
- A history of angioedema related or not to previous treatment with ACEI,
- Impaired renal function defined as serum creatinine levels > 177 µmol/L, eGFR <30 mL/min,
- Hyperkalemia or hypokalemia,
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- Severe hepatic impairment,
- Use of non-antiarrhythmic agents causing torsade de pointes,
- Pregnant or lactating women, or who are planning to become pregnant,
- Any conditions which may impact on participation according to treating physician.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Medpharmgene
Montreal, Quebec, H1Y 3L1
Marie-Renée Guertin, Project manager, 514 249 4209 ext. 222, m-r.guertin@medpharmgene.ca
Pavel Hamet
About this study
Official title: A Multicentre Study to Evaluate the Management of Microalbuminuria in Hypertensive Patients With Type 2 Diabetes: Improving Clinical Practice
Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin to usual practice on quality of care in hypertensive patients with Type 2 diabetes.
- Conditions
- Microalbuminuria, Hypertension, Type 2 Diabetes
- Keywords
- Microalbuminuria, Hypertensive, Diabetics, urine albumin
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Stabilisation or improvement of urine albumin excretion status by at least one stage
Measured: 1 year
Secondary outcomes (1)
Microalbuminuria (or further stages of CKD) after 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroalbuminuriaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Medpharmgene, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907958
- Sponsor's protocol ID
- CLINPRADIA
- Acronym
- CLINPRADIA
- Status last verified
- Jul 2013
- First submitted
- 18 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Study to Evaluate the Management of Microalbuminuria in Hypertensive Patients With Type 2 Diabetes: Improving Clinical Practice
- ClinicalTrials.gov ID
- NCT01907958
- Acronym / sponsor ID
- CLINPRADIA / CLINPRADIA
- Conditions
- Microalbuminuria, Hypertension, Type 2 Diabetes
- Keywords
- Microalbuminuria, Hypertensive, Diabetics, urine albumin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Medpharmgene, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 25 Jul 2013 (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.
Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin to usual practice on quality of care in hypertensive patients with Type 2 diabetes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years and older Uncontrolled blood pressure Type 2 diabetes
Key inclusion criteria (4 listed)
- Male or female 18 years and older and able to visit the study sites every 3 months
- T2D patients with ongoing anti-diabetic therapy for at least 5 years
- Uncontrolled hypertension according to 2012 CHEP recommendations for management of hypertension in diabetic patients ( i.e. BP> 130/80 mmHg)
- Able and agreeing to provide informed consent.
Key exclusion criteria (10 listed)
- Type 1 diabetes patients
- Ongoing therapy with perindopril,
- Known hypersensitivity or allergies to ACEI or sulfonamide derivatives,
- A history of angioedema related or not to previous treatment with ACEI,
- Impaired renal function defined as serum creatinine levels > 177 µmol/L, eGFR <30 mL/min,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stabilisation or improvement of urine albumin excretion status by at least one stage
Time frame: 1 year
1 secondary outcome
Microalbuminuria (or further stages of CKD) after 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microalbuminuria and Hypertension, run by Medpharmgene, Inc. at 1 site in Canada.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 25 Jul 2013. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Renée GUERTIN, project manager (514 249 4209 ext. 222, m-r.guertin@medpharmgene.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stabilisation or improvement of urine albumin excretion status by at least one stage (time frame: 1 year). 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 25 Jul 2013.