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

NCT02410005 | Terminated Phase 2 DMC

• 2 other identifiers: 14-00039NPRP No: 4-1392-3-345
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 3

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.

Conditions

Diabetic Nephropathies

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (4)

• Urine mRNA/miRNA expression

  15 months

• Urine Albumin-to-Creatinine Ratio (UACR)

  15 months

• Blood Pressure (BP)

  15 months

Study Arms (2)

Losartan alone

ACTIVE COMPARATOR

In the losartan alone group, subjects are prescribed: losartan 50mg twice daily.

Drug: Losartan

Losartan and Calcitriol

EXPERIMENTAL

In the losartan plus calcitriol group, subjects are prescribed: losartan 50mg twice daily and calcitriol 0.25mcg daily.

Dietary Supplement: Calcitriol; Drug: Losartan

Interventions

Calcitriol DIETARY_SUPPLEMENT

Also known as: 1,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3

Losartan and Calcitriol

Losartan DRUG

Losartan alone; Losartan and Calcitriol

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of T2DM requiring treatment with at least one oral hypoglycemic medication or insulin
• 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
• Estimated eGFR of 30 to 90 mL/min/1.73 m2

You may not qualify if:

• Positive Pregnancy Test or planning pregnancy in the subsequent 18months (if female)
• Serum Calcium \> 2.45 mmol/L (9.8 mg/dL)
• Serum Phosphorus \> 1.78 mmol/L (5.5 mg/dL)
• Serum Potassium \> 5.5 mmol/L (5 mEq/L)
• Parathyroid hormone \< 20 pg/mL or \> 500 pg/mL
• Hemoglobin A1C \> 12%
• OH Vit D \> 50 ng/mL
• Poorly controlled hypertension defined as systolic blood pressure \>= 180 mm Hg or diastolic blood pressure \>= 110 mm Hg
• History of kidney stones
• History of severe disease like chronic liver disease
• Active malignancy
• Active granulomatous diseases like turburculosis and sarcoidosis
• Recent diagnosis of acute renal failure within 3 months of screening visit
• Likelihood of renal replacement therapy within 1 year
• History of parathyroidectomy

Sponsors & Collaborators

• Weill Cornell Medical College in Qatar: lead
• Hamad Medical Corporation: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (3)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Weill Cornell Medical College in Qatar

Doha, 24144, Qatar

Location

Hamad Medical Corporation

Doha, Qatar

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Calcitriol; Losartan

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Phyllis August, MD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: April 7, 2015
• Study Start: October 1, 2014
• Primary Completion: September 7, 2015
• Study Completion: September 7, 2015
• Last Updated: June 15, 2017

Record last verified: 2017-06

Locations

US (1); QA (2)