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

NCT ID: NCT02410005

Last Updated: 2017-06-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-09-07

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.

Conditions

Diabetic Nephropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Losartan alone

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

Group Type: ACTIVE_COMPARATOR

Losartan

Intervention Type: DRUG

Losartan and Calcitriol

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

Group Type: EXPERIMENTAL

Calcitriol

Intervention Type: DIETARY_SUPPLEMENT

Losartan

Intervention Type: DRUG

Interventions

Calcitriol

Intervention Type: DIETARY_SUPPLEMENT

Losartan

Intervention Type: DRUG

Other Intervention Names

1,25-dihydroxycholecalciferol; 1,25-dihydroxyvitamin D3

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Weill Cornell Medical College in Qatar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phyllis August, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College

New York, New York, United States

Weill Cornell Medical College in Qatar

Doha, , Qatar

Hamad Medical Corporation

Doha, , Qatar

Countries

United States; Qatar

Other Identifiers

NPRP No: 4-1392-3-345

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

14-00039

Identifier Type: OTHER

Identifier Source: secondary_id

14-00039

Identifier Type: -

Identifier Source: org_study_id