Overview

This trial is active, not recruiting.

Condition diabetic nephropathies
Treatments calcitriol, losartan
Phase phase 2/phase 3
Sponsor Weill Cornell Medical College in Qatar
Collaborator Weill Medical College of Cornell University
Start date October 2014
End date January 2018
Trial size 56 participants
Trial identifier NCT02410005, 14-00039, NPRP No: 4-1392-3-345

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
In the losartan alone group, subjects are prescribed: losartan 50mg twice daily.
losartan
(Experimental)
In the losartan plus calcitriol group, subjects are prescribed: losartan 50mg twice daily and calcitriol 0.25mcg daily.
calcitriol 1,25-dihydroxycholecalciferol
losartan

Primary Outcomes

Measure
24h urine 24hr urine albuminuria
time frame: 12 month

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

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

Additional Information

Official title Kidney Disease in Type 2 Diabetes Mellitus: Biomarker Discovery and Novel Therapeutics
Principal investigator Phyllis August, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Weill Cornell Medical College in Qatar.