Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02410005
Recruitment Status : Terminated (Logistic challenges)
First Posted : April 7, 2015
Last Update Posted : June 15, 2017
Sponsor:
Collaborators:
Hamad Medical Corporation
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Weill Cornell Medical College in Qatar

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : October 2014
Actual Primary Completion Date : September 7, 2015
Actual Study Completion Date : September 7, 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 24h urine 24hr urine albuminuria [ Time Frame: 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 [ Time Frame: 15 months ]
  2. Urine Albumin-to-Creatinine Ratio (UACR) [ Time Frame: 15 months ]
  3. Blood Pressure (BP) [ Time Frame: 15 months ]
  4. Estimated glomuerula filtration rate (eGFR) [ Time Frame: 15 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410005


Locations
Layout table for location information
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Qatar
Weill Cornell Medical College in Qatar
Doha, Qatar, 24144
Hamad Medical Corporation
Doha, Qatar
Sponsors and Collaborators
Weill Cornell Medical College in Qatar
Hamad Medical Corporation
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Phyllis August, MD, MPH Weill Medical College of Cornell University

Layout table for additonal information
Responsible Party: Weill Cornell Medical College in Qatar
ClinicalTrials.gov Identifier: NCT02410005     History of Changes
Other Study ID Numbers: 14-00039
NPRP No: 4-1392-3-345 ( Other Grant/Funding Number: Qatar National Research Fund )
14-00039 ( Other Identifier: HMC/WCMC-Q JIRB )
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Calcitriol
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Dihydroxycholecalciferols
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents