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

• Sponsor: Weill Cornell Medical College in Qatar (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02410005
• Collaborator: Hamad Medical Corporation (Industry), Weill Medical College of Cornell University (Other)
• Enrollment: 56
• Locations: 3
• Arms: 2
• Duration (Months): 11.2
• Patients Per Site: 18.7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathies	Dietary Supplement: Calcitriol; Drug: Losartan	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Kidney Disease in Type 2 Diabetes Mellitus: Biomarker Discovery and Novel Therapeutics
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Sep 7, 2015
• Actual Study Completion Date: Sep 7, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Losartan alone In the losartan alone group, subjects are prescribed: losartan 50mg twice daily.	Drug: Losartan
Experimental: Losartan and Calcitriol In the losartan plus calcitriol group, subjects are prescribed: losartan 50mg twice daily and calcitriol 0.25mcg daily.	Dietary Supplement: Calcitriol; Other Names: 1,25-dihydroxycholecalciferol 1,25-dihydroxyvitamin D3 ; Drug: Losartan

Outcome Measures

Primary Outcome Measures

1. 24h urine 24hr urine albuminuria [12 month]

   24h urine albuminuria (log transformed) from baseline to 12 months post-randomization in the losartan plus calcitriol group compared to the losartan alone group.

Other Outcome Measures

1. Urine mRNA/miRNA expression [15 months]

2. Urine Albumin-to-Creatinine Ratio (UACR) [15 months]

3. Blood Pressure (BP) [15 months]

4. Estimated glomuerula filtration rate (eGFR) [15 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College	New York	New York	United States	10021
2	Weill Cornell Medical College in Qatar	Doha		Qatar	24144
3	Hamad Medical Corporation	Doha		Qatar

Sponsors and Collaborators

• Weill Cornell Medical College in Qatar
• Hamad Medical Corporation
• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Phyllis August, MD, MPH, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Cornell Medical College in Qatar
• ClinicalTrials.gov Identifier: NCT02410005
• Other Study ID Numbers: 14-00039; NPRP No: 4-1392-3-345; 14-00039
• First Posted: Apr 7, 2015
• Last Update Posted: Jun 15, 2017
• Last Verified: Jun 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetic Nephropathies; Calcitriol; Dihydroxycholecalciferols; Losartan

Study Results

No Results Posted as of Jun 15, 2017