Intervention Using Vitamin D for Elevated Urinary Albumin Treated With Losartan in Diabetes (IDEAL)

Cornell University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Diabetic Nephropathies

Treatments: Drug: Losartan; Dietary Supplement: Calcitriol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02410005

NPRP No: 4-1392-3-345 (Other Grant/Funding Number)

14-00039 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Losartan alone

Active Comparator group

Description:

In the losartan alone group, subjects are prescribed: losartan 50mg twice daily.

Treatment:

Drug: Losartan

Losartan and Calcitriol

Experimental group

Description:

In the losartan plus calcitriol group, subjects are prescribed: losartan 50mg twice daily and calcitriol 0.25mcg daily.

Treatment:

Dietary Supplement: Calcitriol

Drug: Losartan