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Diabetic NephropathiesPhase 3IDEAL-2NCT03216564

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

A Phase 3 study testing Calcitriol in people with Diabetic Nephropathies, run by Hamad Medical Corporation at 1 site in Qatar.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Nephropathies
What is being tested?
Calcitriol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteQatar
Study dates
10 May 2017to 10 May 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Shahrad Taheri, MB BS PhD contact

0097444928998

szt2004@qatar-med.cornell.edu

Muhammad Asim, MB BS contact

0097455838342

Masim@hamad.qa

Qatar1 site, 1 recruiting

  • Hamad Medical Corporation

    Doha

    Muhammad Asim, MB BS, 0097455838342, Masim@hamad.qa

    Muhammad Asim, MB BS

    Recruiting

Other trials in Qatar

About this study

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

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.

Read the 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.

Being tested
Calcitriol
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CalcitriolDrug

    Also called Active Vitamin D

    Active vitamin D (Calcitriol) 0.25 micrograms

Study groups in NCT03216564
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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.
Receives: Drug: Calcitriol
Usual CareNo interventionParticipants are treated with ACEI/ARB alone for 26 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urinary albumin creatinine ratio (ACR) measured biochemically

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

    Measured: 26 weeks

Secondary outcomes (3)

  1. 24-hour urine albumin (24h UA) excretion

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

    Measured: 26 weeks

  2. Estimated glomerular filtration rate (eGFR)

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

    Measured: 26 weeks

  3. Blood pressure

    Blood pressure measured using a digital sphygmomanometer

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2017
  2. Study start10 May 2017
  3. Primary completion10 May 2019 (estimated)
  4. Study completion10 May 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03216564
Sponsor's protocol ID
16235/16
Other IDs
1400039
Acronym
IDEAL-2
Status last verified
Jul 2018
First submitted
19 Jun 2017
Last updated
6 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: For data, please contact investigators

Publications

  • 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.

    PubMed 29665833

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calcitriol in people with Diabetic Nephropathies, run by Hamad Medical Corporation at 1 site in Qatar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shahrad Taheri, MB BS PhD (0097444928998, szt2004@qatar-med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary albumin creatinine ratio (ACR) measured biochemically (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03216564, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.

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