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An Intervention to Examine the Effect of Vitamin D on Urine Protein Levels in Type 2 Diabetes (IDEAL-2)

Primary Purpose

Diabetic Nephropathies

Status

Unknown status

Phase

Phase 3

Locations

Qatar

Study Type

Interventional

Intervention

Calcitriol

About this trial

This is an interventional treatment trial for Diabetic Nephropathies

Eligibility Criteria

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

Inclusion Criteria:

Age greater than or equal to 18 years and less than 80 years
Diagnosis of T2DM requiring treatment with at least one oral hypoglycaemic medication or insulin 2.1. Subjects will be considered to have established T2DM if the diagnosis of diabetes has been made and the subjects were treated with insulin or an oral hypoglycaemic agent for at least 6 months after diagnosis 2.2. Subjects will be considered to have newly established T2DM if the diagnosis of diabetes was diagnosed with a fasting plasma glucose ≥ 7 mmol/L (126 mg/dL) or haemoglobin A1c is >6.5% in the past 6 months
Documented albuminuria defined as a presence of albuminuria on two occasions in the last six months:
3.1. Albumin ≥ 30 mg/24 hour in a 24 hour urine collection, or 3.2. Albumin ≥ 20 μg/min in a short-time urine collection, or 3.3. Albumin ≥ 30 mg/L in a spot urine sample, or 3.4. A spot-urine albumin-creatinine ration (ACR) ≥ 30 mg/g creatinine (≥ 2.5 mg/mmol creatinine in men, ≥ 3.5 mg/mmol creatinine in women)
Estimated glomerular filtration rate (eGFR) using the 4-variable Modification of Diet in Renal Disease (MDRD) equation of ≥ 25 mL/min/1.73 m2

Exclusion Criteria:

If female, positive pregnancy test or planning pregnancy in the subsequent 12 months
Pregnant
Breastfeeding
Corrected serum calcium ≥ 2.62 mmol/L
Serum Potassium > 5.2 mmol/L if not on ACEI or ARB; Serum Potassium > 6.0 mmol/L if on ACEI or ARB
25-hydroxyvitamin D (25-OH Vit D) > 80 ng/mL
PTH > 200 pg/mL
Poorly controlled hypertension defined as systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg
Systolic blood pressure (SBP) ≤ 110 mm Hg
History of kidney stones
History of severe chronic disease (e.g. chronic liver disease)
Active malignancy
Recent diagnosis of acute renal failure within 3 months of screening visit
Likelihood of renal replacement therapy within 1 year

Sites / Locations

Hamad Medical CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Usual Care

Arm Description

Participants are treated with angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB) AND active vitamin D (Calcitriol) 0.25 micrograms orally per day for 26 weeks.

Participants are treated with ACEI/ARB alone for 26 weeks.

Outcomes

Primary Outcome Measures

Urinary albumin creatinine ratio (ACR) measured biochemically

Urine albumin and creatinine will be measured biochemically and their ratio calculated

Secondary Outcome Measures

24-hour urine albumin (24h UA) excretion

24-hour urine albumin (24h UA) excretion measured biochemically

Estimated glomerular filtration rate (eGFR)

Calculated using the Modification of Diet in Renal Disease (MDRD) equation

Blood pressure

Blood pressure measured using a digital sphygmomanometer

Full Information

NCT ID

NCT03216564

First Posted

June 19, 2017

Last Updated

September 4, 2018

Sponsor

Hamad Medical Corporation

Collaborators

Weill Cornell Medical College in Qatar

1. Study Identification

Unique Protocol Identification Number

NCT03216564

Brief Title

An Intervention to Examine the Effect of Vitamin D on Urine Protein Levels in Type 2 Diabetes

Acronym

IDEAL-2

Official Title

Intervention Using Vitamin D for Elevated Urinary ALbumin in Diabetes (IDEAL-2)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 10, 2017 (Actual)

Primary Completion Date

May 10, 2019 (Anticipated)

Study Completion Date

May 10, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hamad Medical Corporation

Collaborators

Weill Cornell Medical College in Qatar

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

Diabetic kidney disease (nephropathy) develops in nearly 40% of patients with type 2 diabetes mellitus. Diabetic nephropathy is caused by damage to the small blood vessels in the kidneys due to uncontrolled blood sugar levels, which mean that the kidneys become less effective at filtering urine. This is associated with albuminuria (protein in the urine). Treatment with some drugs reduces the loss of albumin through the urine and delays disease progression. There is increasing evidence that vitamin D could also be important in management of diabetic kidney disease. The aim of this study is to investigate the efficacy and safety of a combined regimen of calcitriol (active vitamin D) and established drugs for diabetic kidney disease.

Detailed Description

The investigators propose to test the efficacy and safety of a combined regimen of calcitriol and angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in type 2 diabetes subjects with albuminuria. In the proposed study, the bioactive form of vitamin D (calcitriol) is being used for its ability to synergize with ACEI or ARB and prevent renal disease progression. The study expands on preliminary studies demonstrating a reduction in proteinuria with vitamin D analogue treatment, in subjects with both diabetic as well as non-diabetic kidney disease.

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 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Participants are treated with angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB) AND active vitamin D (Calcitriol) 0.25 micrograms orally per day for 26 weeks.

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Participants are treated with ACEI/ARB alone for 26 weeks.

Intervention Type

Drug

Intervention Name(s)

Calcitriol

Other Intervention Name(s)

Active Vitamin D

Intervention Description

Active vitamin D (Calcitriol) 0.25 micrograms

Primary Outcome Measure Information:

Title

Urinary albumin creatinine ratio (ACR) measured biochemically

Description

Urine albumin and creatinine will be measured biochemically and their ratio calculated

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

24-hour urine albumin (24h UA) excretion

Description

24-hour urine albumin (24h UA) excretion measured biochemically

Time Frame

26 weeks

Title

Estimated glomerular filtration rate (eGFR)

Description

Calculated using the Modification of Diet in Renal Disease (MDRD) equation

Time Frame

26 weeks

Title

Blood pressure

Description

Blood pressure measured using a digital sphygmomanometer

Time Frame

26 weeks

Other Pre-specified Outcome Measures:

Title

Patient Reported Outcome: Quality of life

Description

Measured using the EQ5D questionnaire

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age greater than or equal to 18 years and less than 80 years Diagnosis of T2DM requiring treatment with at least one oral hypoglycaemic medication or insulin 2.1. Subjects will be considered to have established T2DM if the diagnosis of diabetes has been made and the subjects were treated with insulin or an oral hypoglycaemic agent for at least 6 months after diagnosis 2.2. Subjects will be considered to have newly established T2DM if the diagnosis of diabetes was diagnosed with a fasting plasma glucose ≥ 7 mmol/L (126 mg/dL) or haemoglobin A1c is >6.5% in the past 6 months Documented albuminuria defined as a presence of albuminuria on two occasions in the last six months: 3.1. Albumin ≥ 30 mg/24 hour in a 24 hour urine collection, or 3.2. Albumin ≥ 20 μg/min in a short-time urine collection, or 3.3. Albumin ≥ 30 mg/L in a spot urine sample, or 3.4. A spot-urine albumin-creatinine ration (ACR) ≥ 30 mg/g creatinine (≥ 2.5 mg/mmol creatinine in men, ≥ 3.5 mg/mmol creatinine in women) Estimated glomerular filtration rate (eGFR) using the 4-variable Modification of Diet in Renal Disease (MDRD) equation of ≥ 25 mL/min/1.73 m2 Exclusion Criteria: If female, positive pregnancy test or planning pregnancy in the subsequent 12 months Pregnant Breastfeeding Corrected serum calcium ≥ 2.62 mmol/L Serum Potassium > 5.2 mmol/L if not on ACEI or ARB; Serum Potassium > 6.0 mmol/L if on ACEI or ARB 25-hydroxyvitamin D (25-OH Vit D) > 80 ng/mL PTH > 200 pg/mL Poorly controlled hypertension defined as systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg Systolic blood pressure (SBP) ≤ 110 mm Hg History of kidney stones History of severe chronic disease (e.g. chronic liver disease) Active malignancy Recent diagnosis of acute renal failure within 3 months of screening visit Likelihood of renal replacement therapy within 1 year

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shahrad Taheri, MB BS PhD

Phone

0097444928998

szt2004@qatar-med.cornell.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Muhammad Asim, MB BS

Phone

0097455838342

Masim@hamad.qa

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muhammad Asim, MB BS

Organizational Affiliation

Hamad Medical Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamad Medical Corporation

City

Doha

Country

Qatar

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Muhammad Asim, MB BS

Phone

0097455838342

Masim@hamad.qa

First Name & Middle Initial & Last Name & Degree

Muhammad Asim, MB BS

First Name & Middle Initial & Last Name & Degree

Shahrad Taheri, MB BS PhD

First Name & Middle Initial & Last Name & Degree

Phyllis August, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

For data, please contact investigators

Citations:

PubMed Identifier

29665833

Citation

Taheri S, Asim M, Al Malki H, Fituri O, Suthanthiran M, August P; IDEAL-2 Study Team. Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial. Trials. 2018 Apr 17;19(1):230. doi: 10.1186/s13063-018-2616-5.

Results Reference

derived

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An Intervention to Examine the Effect of Vitamin D on Urine Protein Levels in Type 2 Diabetes

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