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

Diabetic Nephropathies Clinical Trial

— IDEAL  

Official title:

Kidney Disease in Type 2 Diabetes Mellitus: Biomarker Discovery and Novel Therapeutics

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02410005
• Other study ID #: 14-00039
• Secondary ID: NPRP No: 4-1392-
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: February 18, 2015
• Last updated: June 13, 2017
• Start date: October 2014
• Est. completion date: September 7, 2015

Study information

• Verified date: June 2017
• Source: Weill Cornell Medical College in Qatar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: September 7, 2015
• Est. primary completion date: September 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies

Intervention

Dietary Supplement:
• Calcitriol

Drug:
• Losartan

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha
Qatar	Weill Cornell Medical College in Qatar	Doha
United States	Weill Cornell Medical College	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Cornell Medical College in Qatar	Hamad Medical Corporation, Weill Medical College of Cornell University

Countries where clinical trial is conducted

United States,  Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urine mRNA/miRNA expression		15 months
Other	Urine Albumin-to-Creatinine Ratio (UACR)		15 months
Other	Blood Pressure (BP)		15 months
Other	Estimated glomuerula filtration rate (eGFR)		15 months
Primary	24h urine 24hr urine albuminuria	24h urine albuminuria (log transformed) from baseline to 12 months post-randomization in the losartan plus calcitriol group compared to the losartan alone group.	12 month