Vitamin-D Receptor Activation (VDRA) in Chronic Kidney Disease

NCT01204528 | Completed Phase 2 DMC

• 1 other identifier: VDRA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether treatment with a vitamin-D receptor activator is able to improve important markers of cardiovascular risk.

Conditions

Chronic Kidney Disease

Keywords

Dysfunction in CKD

Outcome Measures

Primary Outcomes (1)

• A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography.

  Sympathetic activation is closely related to severity and progression of cardiovascular diseases, and renovascular dysfunction. We will directly measure sympathetic activation using microneurography (muscle sympathetic nerve activity; MSNA), expressed as bursts/minute and bursts/100 RR-interval. As this is a physiological study, the primary outcome will constitute a significant reduction in MSNA.

  Measured after 12 weeks treatment.

Secondary Outcomes (1)

• Microcirculatory function measured by laser doppler methods.

  Measured after 12 weeks treatment.

Study Arms (3)

Paricalcitol 2 microgram/d

ACTIVE COMPARATOR

Drug: Zemplar

Paricalcitol 1 microgram/d

ACTIVE COMPARATOR

Drug: Zemplar

Placebo

PLACEBO COMPARATOR

Drug: Zemplar

Interventions

Zemplar DRUG

Vitamin D receptor activator (VDRA)

Paricalcitol 1 microgram/d; Paricalcitol 2 microgram/d; Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eGFR 15-59 ml/m2

You may not qualify if:

• Current vitamin D treatment

Sponsors & Collaborators

• Danderyd Hospital: lead
• Abbott: collaborator

Study Sites (1)

Karolinska Institute at Danderyd University Hospital

Danderyd, Stockholm County, 18288, Sweden

Location

Related Publications (3)

• Lundwall K, Mortberg J, Mobarrez F, Jacobson SH, Jorneskog G, Spaak J. Changes in microparticle profiles by vitamin D receptor activation in chronic kidney disease - a randomized trial. BMC Nephrol. 2019 Aug 1;20(1):290. doi: 10.1186/s12882-019-1445-4.

  PMID: 31370809 DERIVED

• Mansouri L, Lundwall K, Moshfegh A, Jacobson SH, Lundahl J, Spaak J. Vitamin D receptor activation reduces inflammatory cytokines and plasma MicroRNAs in moderate chronic kidney disease - a randomized trial. BMC Nephrol. 2017 May 16;18(1):161. doi: 10.1186/s12882-017-0576-8.

  PMID: 28511692 DERIVED

• Lundwall K, Jorneskog G, Jacobson SH, Spaak J. Paricalcitol, Microvascular and Endothelial Function in Non-Diabetic Chronic Kidney Disease: A Randomized Trial. Am J Nephrol. 2015;42(4):265-73. doi: 10.1159/000441364. Epub 2015 Oct 24.

  PMID: 26496210 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: September 17, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

SE (1)