Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients (SENPARIC)

Paricalcitol Action on Parameters of Inflammation and Oxidative Stress in Patients With Chronic Kidney Disease Stage Vd Carriers Tunneled Hemodialysis Catheters

Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Paricalcitol; Drug: Paricalcitol, atorvastatin; Drug: Atorvastatin

Detailed Description

Use of Paricalcitol in stage Vd Chronic Kidney Disease patients using a permanent catheter due to haemodialysis; over the effect of inflammatory and oxidative stress parameters. This study uses paricalcitol (vitamin D) versus atorvastatin versus paricalcitol plus atorvastatin treatments.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • León, Spain, 24008
    • Hospital de Leon
  • (León).
    • Ponferrada, (León)., Spain, 24411,
      • Hospital El Bierzo. Servicio de Nefrología.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Vd CKD patients using haemodialysis during 3 or more months.
• Tunnelized-bearer permanent catheters on haemodialysis at last 6 months previous at the beginning of the study. .
• Kt stable, over 45 litres on both sexs.
• Patients in treatment wiht atorvastatin
• Patients without infectious or inflammatory processes over 8 weeks.
• Two consecutive PTH < than 400 pg/ml; Ca<10.2 and P <7.0 mg/dl.

Exclusion Criteria:

• Patients > 18 years.
• Pregnant women.
• Patients hospitalized 4 weeks before the beginning of the treatment.
• Immunosuppressor intake.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paricalcitol; SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week.	Drug: Paricalcitol; Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.; Other Names: Group 1
Active Comparator: Paricalcitol, Atorvastatin; SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg)	Drug: Paricalcitol, atorvastatin; Oral Paricalcitol. parathyroid hormone i mgc/100. 3 days a week, the same day as haemodialysis, during 12 weeks. Atorvastatin: 20 mg/day oral (1 take) during 12 weeks.; Other Names: G2
Active Comparator: Atorvastatin; SUBGROUP 3 (G3): Atorvastatin (same G2 dosis)	Drug: Atorvastatin; Atorvastatin: 20 mg/day oral (1 take) during 12 weeks; Other Names: G3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment	Measure parameter: IL-2	12 weeks of treatment wiht visits and analysis
Oxidative stress and inflammative parameters	Measure unit: IL-4	12 weeks of treatment
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	IL-5	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	IL-6	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	IL-10	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	IL-13	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	TNF-beta	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	CD3	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	CD4	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	CD8	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	CD19	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	CD25	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	CD56	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	CD69	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	CD95	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	COX-2	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	iNOS	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	PGE2	12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment	FGF-23	12 weeks of treatment with visits and analysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Parameters	Weight	12 weeks of treatment with visits and analysis
Erythropoietin requirements variations	Fe	12 weeks of treatment with visits and analysis
Assess potential benefits inflammatory markers	PTHi	12 weeks of treatment with visits and analysis
Nutritional Parameters	Height	12 weeks of treatment with visits and analysis
Nutritional Parameters	Body Mass Index (BMI)	12 weeks of treatment with visits and analysis
Nutritional Parameters	Abdominal circumference	12 weeks of treatment with visits and analysis
Nutritional Parameters	Triceps skin fold circumference	12 weeks of treatment with visits and analysis
Nutritional Parameters	Bioimpedance	12 weeks of treatment with visits and analysis
Anaemia parameters	Hemogram	12 weeks of treatment
Anaemia Parameters	Biochemistry	12 weeks of treatment
Erythropoietin requirement variations	Ferritin	12 weeks of treatment with visits and analysis
Erythropoietin requirement variations	Transferrin saturation index	12 weeks of treatment with visits and analysis
Erythropoietin requirements variations	B12	12 weeks of treatment with visits and analysis
Erythropoietin requirements variations	Folic Acid	12 weeks of treatment with visits and analysis
Assess potential benefits in inflammatory markers	Kt	16 weeks, the complete duration of the study

Collaborators and Investigators

• Sponsor: Ricardo Mouzo Mirco
• Investigators: Principal Investigator: Ricardo Mouzo Mirco, MD, Hospital El Bierzo, Fuentesnuevas Ponferrada

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimate): March 29, 2013

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Atorvastatin; Paricalcitol; Vd-stadium.; Inflammatory patterns
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Micronutrients; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Atorvastatin; Ergocalciferols
• Other Study ID Numbers: SENPARIC-2011-01