Back to results

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

Primary Purpose

Diabetic Nephropathies

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Calcitriol

Losartan

About this trial

This is an interventional treatment trial for Diabetic Nephropathies

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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%
25-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
Currently taking calcitriol or 1,25-dihydroxyvitamin D analog
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)
History of osteoporosis or other bone disorder requiring calcitriol therapy
History of allergic reaction to calcitriol, paracalcitol, hectoral, or other 1,25-dihydroxyvitamin D analogs
History of allergic reaction to losartan or any other angiotensin receptor blocker therapy
Evidence of drug or alcohol abuse

Sites / Locations

Weill Cornell Medical College
Weill Cornell Medical College in Qatar
Hamad Medical Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Losartan alone

Losartan and Calcitriol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02410005

First Posted

February 18, 2015

Last Updated

June 13, 2017

Sponsor

Weill Cornell Medical College in Qatar

Collaborators

Hamad Medical Corporation, Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT02410005

Brief Title

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

Acronym

IDEAL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Logistic challenges

Study Start Date

October 2014 (undefined)

Primary Completion Date

September 7, 2015 (Actual)

Study Completion Date

September 7, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Cornell Medical College in Qatar

Collaborators

Hamad Medical Corporation, Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Losartan alone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Losartan and Calcitriol

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcitriol

Other Intervention Name(s)

1,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3

Intervention Type

Drug

Intervention Name(s)

Losartan

Primary Outcome Measure Information:

Title

24h urine 24hr urine albuminuria

Description

24h urine albuminuria (log transformed) from baseline to 12 months post-randomization in the losartan plus calcitriol group compared to the losartan alone group.

Time Frame

12 month

Other Pre-specified Outcome Measures:

Title

Urine mRNA/miRNA expression

Time Frame

15 months

Title

Urine Albumin-to-Creatinine Ratio (UACR)

Time Frame

15 months

Title

Blood Pressure (BP)

Time Frame

15 months

Title

Estimated glomuerula filtration rate (eGFR)

Time Frame

15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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% 25-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 Currently taking calcitriol or 1,25-dihydroxyvitamin D analog 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) History of osteoporosis or other bone disorder requiring calcitriol therapy History of allergic reaction to calcitriol, paracalcitol, hectoral, or other 1,25-dihydroxyvitamin D analogs History of allergic reaction to losartan or any other angiotensin receptor blocker therapy Evidence of drug or alcohol abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phyllis August, MD, MPH

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Weill Cornell Medical College in Qatar

City

Doha

ZIP/Postal Code

24144

Country

Qatar

Facility Name

Hamad Medical Corporation

City

Doha

Country

Qatar

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs