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

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.

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