Diabetic NephropathiesPhase 2/3IDEALNCT02410005
Intervention Using Vitamin D for Elevated Urinary Albumin Treated With Losartan in Diabetes (IDEAL)
A Phase 2/3 study testing Calcitriol and Losartan in people with Diabetic Nephropathies, run by Weill Cornell Medical College in Qatar at 3 sites in 2 countries.
Trial summary
This study is a single center open-label randomized controlled trial designed to evaluate the efficacy of calcitriol plus losartan therapy in subjects with type II diabetes and macroalbuminuria. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Calcitriol and Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2014to 7 Sep 2015
- Phase
- Phase 2/3
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of T2DM requiring treatment with at least one oral hypoglycemic medication or insulin
- Macroalbuminuria as defined as the presence of a UACR greater than 300 mg/gm creatinine (30 mg/mmol creatinine) on two occasions in the last six months
- Estimated eGFR of 30 to 90 mL/min/1.73 m2
Who cannot join
- Positive Pregnancy Test or planning pregnancy in the subsequent 18months (if female)
- Serum Calcium > 2.45 mmol/L (9.8 mg/dL)
- Serum Phosphorus > 1.78 mmol/L (5.5 mg/dL)
- Serum Potassium > 5.5 mmol/L (5 mEq/L)
- Parathyroid hormone < 20 pg/mL or > 500 pg/mL
- Hemoglobin A1C > 12%
Show all 21Show fewer
- 25-OH Vit D > 50 ng/mL
- Poorly controlled hypertension defined as systolic blood pressure >= 180 mm Hg or diastolic blood pressure >= 110 mm Hg
- History of kidney stones
- History of severe disease like chronic liver disease
- Active malignancy
- Active granulomatous diseases like turburculosis and sarcoidosis
- Recent diagnosis of acute renal failure within 3 months of screening visit
- Likelihood of renal replacement therapy within 1 year
- History of parathyroidectomy
- Currently taking calcitriol or 1,25-dihydroxyvitamin D analog
- Currently taking calcitonin, bisphosphonates, cinacalcet, teriparatide, glucocorticoids or other drugs that may affect calcium or bone metabolism (subjects may be taking calcium containing phosphate binder or other phosphate binder. Subjects may also be taking stable dose of estrogen/progestin)
- History of osteoporosis or other bone disorder requiring calcitriol therapy
- History of allergic reaction to calcitriol, paracalcitol, hectoral, or other 1,25-dihydroxyvitamin D analogs
- History of allergic reaction to losartan or any other angiotensin receptor blocker therapy
- Evidence of drug or alcohol abuse
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Qatar2 sites
Weill Cornell Medical College in Qatar
Doha, 24144
Hamad Medical Corporation
Doha
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: Kidney Disease in Type 2 Diabetes Mellitus: Biomarker Discovery and Novel Therapeutics
This study is a single center open-label randomized controlled trial designed to evaluate the efficacy of calcitriol plus losartan therapy in subjects with type II diabetes and macroalbuminuria.
Read the detailed description
The investigators propose to test the efficacy and safety of a combined regimen of calcitriol and losartan in subjects with type II diabetes (T2DM) with macroalbuminuria. Should the investigators study confirm the hypothesis that the proposed novel regimen is superior to the current practice of renin-angiotensin-aldosterone system blockade, the study would significantly advance the care of subjects with type II diabetes and kidney disease in Qatar and worldwide. In this regard it is worth noting that the prevalence of end stage renal disease in Qatar is 202 subjects per million population. This would translate into fewer subjects requiring dialysis or transplantation, an enormous benefit to individuals and society.
- Conditions
- Diabetic Nephropathies
- Being tested
- Calcitriol, Losartan
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDietary supplement
Also called 1,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3
LosartanDrug
| Study group | Role | What they receive |
|---|---|---|
| Losartan alone | Active comparator | In the losartan alone group, subjects are prescribed: losartan 50mg twice daily. Receives: Drug: Losartan |
| Losartan and Calcitriol | Experimental | In the losartan plus calcitriol group, subjects are prescribed: losartan 50mg twice daily and calcitriol 0.25mcg daily. Receives: Dietary Supplement: Calcitriol; Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h urine 24hr urine albuminuria
24h urine albuminuria (log transformed) from baseline to 12 months post-randomization in the losartan plus calcitriol group compared to the losartan alone group.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startOct 2014
- Primary completion7 Sep 2015
- Study completion7 Sep 2015
Why it stopped: Logistic challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Cornell Medical College in Qatar
- Sponsor type
- University, hospital or other
- Collaborators
- Hamad Medical Corporation, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Phyllis August, MD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410005
- Sponsor's protocol ID
- 14-00039
- Other IDs
- NPRP No: 4-1392-3-345, 14-00039
- Acronym
- IDEAL
- Status last verified
- Jun 2017
- First submitted
- 18 Feb 2015
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Disease in Type 2 Diabetes Mellitus: Biomarker Discovery and Novel Therapeutics
- ClinicalTrials.gov ID
- NCT02410005
- Acronym / sponsor ID
- IDEAL / 14-00039
- Conditions
- Diabetic Nephropathies
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistic challenges
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Weill Cornell Medical College in QatarUniversity, hospital or other
- Collaborators
- Hamad Medical Corporation, Weill Medical College of Cornell University
- Study start
- Oct 2014
- Primary completion
- 7 Sep 2015 (actual)
- Study completion
- 7 Sep 2015 (actual)
- First posted
- 7 Apr 2015 (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.
This study is a single center open-label randomized controlled trial designed to evaluate the efficacy of calcitriol plus losartan therapy in subjects with type II diabetes and macroalbuminuria.
Detailed description
The investigators propose to test the efficacy and safety of a combined regimen of calcitriol and losartan in subjects with type II diabetes (T2DM) with macroalbuminuria. Should the investigators study confirm the hypothesis that the proposed novel regimen is superior to the current practice of renin-angiotensin-aldosterone system blockade, the study would significantly advance the care of subjects with type II diabetes and kidney disease in Qatar and worldwide. In this regard it is worth noting that the prevalence of end stage renal disease in Qatar is 202 subjects per million population. This would translate into fewer subjects requiring dialysis or transplantation, an enormous benefit to individuals and society.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan alone | Active comparator | Drug: LosartanIn the losartan alone group, subjects are prescribed: losartan 50mg twice daily. |
| Losartan and Calcitriol | Experimental | Dietary Supplement: Calcitriol, Drug: LosartanIn the losartan plus calcitriol group, subjects are prescribed: losartan 50mg twice daily and calcitriol 0.25mcg daily. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of T2DM requiring treatment with at least one oral hypoglycemic medication or insulin
- Macroalbuminuria as defined as the presence of a UACR greater than 300 mg/gm creatinine (30 mg/mmol creatinine) on two occasions in the last six months
- Estimated eGFR of 30 to 90 mL/min/1.73 m2
Key exclusion criteria (21 listed)
- Positive Pregnancy Test or planning pregnancy in the subsequent 18months (if female)
- Serum Calcium > 2.45 mmol/L (9.8 mg/dL)
- Serum Phosphorus > 1.78 mmol/L (5.5 mg/dL)
- Serum Potassium > 5.5 mmol/L (5 mEq/L)
- Parathyroid hormone < 20 pg/mL or > 500 pg/mL
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 |
|---|---|---|
| CalcitriolAlso: 1,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3 | Dietary supplement | Losartan and Calcitriol |
| Losartan | Drug | Losartan alone, Losartan and Calcitriol |
Primary outcome
24h urine 24hr urine albuminuria
Time frame: 12 month
24h urine albuminuria (log transformed) from baseline to 12 months post-randomization in the losartan plus calcitriol group compared to the losartan alone group.
Results and safety
The study was stopped early (reason given: Logistic challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
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Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2
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.
Phyllis August, MD, MPH principal investigator
Weill Medical College of Cornell University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Calcitriol and Losartan in people with Diabetic Nephropathies, run by Weill Cornell Medical College in Qatar at 3 sites in 2 countries.
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 21 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: stopped early, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Qatar, United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Logistic challenges). Results are not available in the source record.
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?
24h urine 24hr urine albuminuria (time frame: 12 month). 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 15 Jun 2017.