Clinical trial NCT02410005: Intervention Using Vitamin D for Elevated Urinary Albumin Treated With Losartan in Diabetes (IDEAL)
Official title: Kidney Disease in Type 2 Diabetes Mellitus: Biomarker Discovery and Novel Therapeutics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Diabetic Nephropathies
Lead sponsor: Weill Cornell Medical College in Qatar
Sponsor class: OTHER
Collaborators: name: Hamad Medical Corporation
name: Weill Medical College of Cornell University
First posted: 2015-04-07
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of T2DM requiring treatment with at least one oral hypoglycemic medication or insulin
2. 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
3. Estimated eGFR of 30 to 90 mL/min/1.73 m2

Exclusion Criteria:

1. Positive Pregnancy Test or planning pregnancy in the subsequent 18months (if female)
2. Serum Calcium \> 2.45 mmol/L (9.8 mg/dL)
3. Serum Phosphorus \> 1.78 mmol/L (5.5 mg/dL)
4. Serum Potassium \> 5.5 mmol/L (5 mEq/L)
5. Parathyroid hormone \< 20 pg/mL or \> 500 pg/mL
6. Hemoglobin A1C \> 12%
7. 25-OH Vit D \> 50 ng/mL
8. Poorly controlled hypertension defined as systolic blood pressure \>= 180 mm Hg or diastolic blood pressure \>= 110 mm Hg
9. History of kidney stones
10. History of severe disease like chronic liver disease
11. Active malignancy
12. Active granulomatous diseases like turburculosis and sarcoidosis
13. Recent diagnosis of acute renal failure within 3 months of screening visit
14. Likelihood of renal replacement therapy within 1 year
15. History of parathyroidectomy
16. Currently taking calcitriol or 1,25-dihydroxyvitamin D analog
17. 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)
18. History of osteoporosis or other bone disorder requiring calcitriol therapy
19. History of allergic reaction to calcitriol, paracalcitol, hectoral, or other 1,25-dihydroxyvitamin D analogs
20. History of allergic reaction to losartan or any other angiotensin receptor blocker therapy
21. Evidence of drug or alcohol abuse

Primary outcomes:
measure: 24h urine 24hr urine albuminuria
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
measure: Urine mRNA/miRNA expression
timeFrame: 15 months
measure: Urine Albumin-to-Creatinine Ratio (UACR)
timeFrame: 15 months
measure: Blood Pressure (BP)
timeFrame: 15 months
measure: Estimated glomuerula filtration rate (eGFR)
timeFrame: 15 months
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Doha
country: Qatar
facility: Weill Cornell Medical College in Qatar
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Weill Medical College of Cornell University
name: Phyllis August, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: