Sympathetic activation, microcirculation, haemostasis and inflammation in diabetic and non-diabetic kidney disease: disease modification by vitamin D receptor activation - VDRA and CKD

• Conditions: Patients with mild to moderate chronic renal failure (CRF; GFR 15-60ml/min; n=26)Patients with mild to moderate CRF and coexisting Diabetes Mellitus (n=26); MedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney disease; MedDRA version: 12.0Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2007-006274-29-SE
• Lead Sponsor: Karolinska Institutet at Danderyd University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Man or woman above 20 years of age.
If woman in reproductive age: not nursing and not pregnant (preseting a negative pregnancy test), and on anticonception therapy.
Calculated GFR between 15-59 mL/min/1.73m2 using MDRD
S-Ca2+ <2.6 mmol/L
iPTH between 35-500 pg/mL
Serum albumin > 3.0 g/dL
Signed informed consent

For inclusion in the diabetes study group:
•Diagnosed type II diabetes, and treated with peroral antidiabetics or insulin the last 12 months
•HbA1c <= 12%

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Changes in ACE-inhibitor medication or ARB within 8 weeks before start of the study.

Nefrotic syndrome
Expected need for dialysis within 6 months after study start
Vitamin D treatment within 6 months before start of the study.
Poorly controlled hypertension with blood pressure >150/100 mmHg (repeated measurements after 15 minutes rest)
Concomitant treatment with drugs affecting bone and calcium metabolism such as kalcitonin, cinacalcet (Mimpara or Parareg), and high dose corticosteroids.
Concomitant treatment with drugs inhibiting or inducing Cytokrom P450 3A.
Known hypersensitivity to any of the substances in study drug or placebo.
Diabetic nefropathy and concurrent glomerulonefritis or nefritis
Acute renal failure within 12 weeks before screening
Other severe chronic disease (AIDS/HIV-positive, cancer, severe heart failure etc.)
Known kidney artery stenosis
Known kidney stone disease
Intake of other investigational medicinal product within 30 days before screening.
Known alcohol or drug abuse
Known low compliance
Not suitable for participation for other reason according to investigators opinion.

Study & Design

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