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

• Status: Terminated
• Trial end date: 2015-09-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Cornell Medical College in Qatar
• Collaborators: Hamad Medical Corporation; Weill Medical College of Cornell University
• Treatments: Calcitriol; Dihydroxycholecalciferols; Losartan

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