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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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