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

June 13, 2017 updated by: Weill Cornell Medical College in Qatar

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar
        • Hamad Medical Corporation
      • Doha, Qatar, 24144
        • Weill Cornell Medical College in Qatar
  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Drug: Losartan
Dietary supplement: Calcitriol
Other Names:
  • 1,25-dihydroxycholecalciferol
  • 1,25-dihydroxyvitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 month

Other Outcome Measures

Outcome Measure
Time Frame
Urine mRNA/miRNA expression
Time Frame: 15 months
15 months
Urine Albumin-to-Creatinine Ratio (UACR)
Time Frame: 15 months
15 months
Blood Pressure (BP)
Time Frame: 15 months
15 months
Estimated glomuerula filtration rate (eGFR)
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Cornell Medical College in Qatar

Collaborators

Weill Medical College of Cornell University
Hamad Medical Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 7, 2015

Study Completion (Actual)

September 7, 2015

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-00039 (Other Identifier: HMC/WCMC-Q JIRB)
  • NPRP No: 4-1392-3-345 (Other Grant/Funding Number: Qatar National Research Fund)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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