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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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To investigate whether treatment with a vitamin-D receptor activator is able to improve important markers of cardiovascular risk.
Main question:
May 12 weeks of VDRA treatment reduce the pathological sympathetic overactivation associated with moderate kidney disease?
Secondary questions aim to thrown light on how VDRAs can reduce albuminuria and CRP, i.e. does VDRA treatment improve (prespecified statistical analyses):
A) diastolic dysfunction? B) capillary microcirculation, and whether ameliorated disturbances relate to improved diastolic dysfunction? C) endothelial dysfunction and arterial stiffness? D) inflammatory activation? E) platelet function and haemostasis? F) levels of antibacterial peptides? G) levels of IGFBP-1 and adiponectin?
Overall design The study is designed as a double-blind, randomised, placebo-controlled trial involving two groups (n=72) of patients: 1) chronic kidney failure (CKD, eGFR 15-59 mL/m2) and 2) chronic kidney failure and concomitant diabetes mellitus (CKD+DM).
It will start with a two-week placebo run-in, followed by randomisation to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol 2 microgram/d | Active Comparator |
| |
| Paricalcitol 1 microgram/d | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zemplar | Drug | Vitamin D receptor activator (VDRA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Microcirculatory function measured by laser doppler methods. | Assessed by skin laser-doppler methodology, and directly by nailfold capillaroscopy. | Measured after 12 weeks treatment. |
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Inclusion Criteria:
eGFR 15-59 ml/m2
Exclusion Criteria:
Current vitamin D treatment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institute at Danderyd University Hospital | Danderyd | Stockholm County | 18288 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31370809 | Derived | 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. | |
| 28511692 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 6, 2016 | |
| Reset | Jun 13, 2016 | |
| Release | Jun 14, 2017 | |
| Reset | Jan 26, 2018 | |
| Release | Jan 12, 2021 | |
| Reset | Jan 29, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 6, 2016 | Jun 13, 2016 | |||
| Jun 14, 2017 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
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| 26496210 | 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. |
| Jan 26, 2018 |
| Jan 12, 2021 | Jan 29, 2021 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |