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

• Sponsor: Hamad Medical Corporation (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03216564
• Collaborator: Weill Cornell Medical College in Qatar (Other)
• Enrollment: 320
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 13.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathies	Drug: Calcitriol	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intervention Using Vitamin D for Elevated Urinary ALbumin in Diabetes (IDEAL-2)
• Actual Study Start Date: May 10, 2017
• Anticipated Primary Completion Date: May 10, 2019
• Anticipated Study Completion Date: May 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group 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.	Drug: Calcitriol; Active vitamin D (Calcitriol) 0.25 micrograms; Other Names: Active Vitamin D
No Intervention: Usual Care Participants are treated with ACEI/ARB alone for 26 weeks.

Outcome Measures

Primary Outcome Measures

1. Urinary albumin creatinine ratio (ACR) measured biochemically [26 weeks]

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

Secondary Outcome Measures

1. 24-hour urine albumin (24h UA) excretion [26 weeks]

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

2. Estimated glomerular filtration rate (eGFR) [26 weeks]

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

3. Blood pressure [26 weeks]

   Blood pressure measured using a digital sphygmomanometer

Other Outcome Measures

1. Patient Reported Outcome: Quality of life [26 weeks]

   Measured using the EQ5D questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age greater than or equal to 18 years and less than 80 years

2. 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

3. 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)

1. 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:

1. If female, positive pregnancy test or planning pregnancy in the subsequent 12 months

2. Pregnant

3. Breastfeeding

4. Corrected serum calcium ≥ 2.62 mmol/L

5. Serum Potassium > 5.2 mmol/L if not on ACEI or ARB; Serum Potassium > 6.0 mmol/L if on ACEI or ARB

6. 25-hydroxyvitamin D (25-OH Vit D) > 80 ng/mL

7. PTH > 200 pg/mL

8. Poorly controlled hypertension defined as systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg

9. Systolic blood pressure (SBP) ≤ 110 mm Hg

10. History of kidney stones

11. History of severe chronic disease (e.g. chronic liver disease)

12. Active malignancy

13. Recent diagnosis of acute renal failure within 3 months of screening visit

14. Likelihood of renal replacement therapy within 1 year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamad Medical Corporation	Doha		Qatar

Sponsors and Collaborators

• Hamad Medical Corporation
• Weill Cornell Medical College in Qatar

Investigators

• Principal Investigator: Muhammad Asim, MB BS, Hamad Medical Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hamad Medical Corporation
• ClinicalTrials.gov Identifier: NCT03216564
• Other Study ID Numbers: 16235/16; 1400039
• First Posted: Jul 13, 2017
• Last Update Posted: Sep 6, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetic Nephropathies; Vitamin D; Calcitriol

Study Results

No Results Posted as of Sep 6, 2018