Intervention Using Vitamin D for Elevated Urinary Albumin Treated With Losartan in Diabetes (IDEAL)
Stopped early · Phase 2/Phase 3
Conditions studied: Diabetic Nephropathies
In brief
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.
Key facts
- Study ID
- NCT02410005
- Run by
- Weill Cornell Medical College in Qatar
- People needed
- 56
- Starts
- 2014-10-01
- Expected to finish
- 2015-09-07
- Last updated by the study team
- 2017-06-15
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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%
- 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
Where it is running
- Weill Cornell Medical College — New York, New York, United States
- Weill Cornell Medical College in Qatar — Doha, Qatar
- Hamad Medical Corporation — Doha, Qatar
Full record on ClinicalTrials.gov
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