Does vitamin D treatment have an effect on arterial stiffness and protein in urine in patients with type 2 diabetes and stage 3 chronic kidney disease

Phase 1

• Conditions: Diabetic kidney disease.; MedDRA version: 17.0 Level: LLT Classification code 10009119 Term: Chronic renal failure System Organ Class: 100000004857; MedDRA version: 17.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2010-018285-23-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-07
• Study Completion: 2018-04-01
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

1.Patients with a diagnosis of T2DM.
2.Patients aged between 40 and 75 years (inclusive).
3.Chronic Kidney disease (CKD) stage 3 [estimated glomerular filtration rate (eGFR*) 30-59 ml/min on the two most recent (within 12 months) consecutive measurements].
4.A history of an elevated urinary albumin excretion rate (UAER) [albumin: creatinine ratio= 2.5 mg/mmol in men and =3mg/mmol in women on more than three occasions or UAER =20mcg/min on at least two timed urine collections or two or more positive urine dipsticks results for proteinuria or two or more urine protein creatinine ratios (PCR)>15 mg/mmol] or clinical evidence of diabetic nephropathy
5.Normal corrected serum calcium (2.1-2.6mmol/l).
6.Normal phosphate (0.8-1.5 mmol/l) levels.
7.A raised intact parathyroid hormone (iPTH) level between 30 pg/ml and 200pg/ml at screening visit or a history of a raised intact parathyroid hormone (iPTH) level between 30 pg/ml and 200pg/ml in the 3 months preceding screening visit.
8.Written informed consent to participate in the study prior to any study procedures.
9.Ability to communicate and comply with all study requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

•An iPTH =200 pg/ml at study entry (a conservative treatment threshold for initiating active vitamin D treatment for prevention of renal osteodystrophy).
•History of non diabetic or obstructive kidney disease.
•Poorly controlled hypertension (systolic and diastolic blood pressure >180mmHg and >110 mmHg respectively).
•Presence of connective tissue diseases known to affect arterial vasculature.
•Atrial fibrillation or other cardiac rhythm disorders.
•Pregnancy or lactation.
•History of a cardiovascular or cerebrovascular event in the preceding 6 months.
•Patients already on vitamin D (inactive or active) treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified