Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients

Chronic Kidney Disease Clinical Trial

— SENPARIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820767
• Other study ID #: SENPARIC-2011-01
• Status: Completed
• Phase: Phase 3
• Start date: August 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2018
• Source: Hospital El Bierzo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT02210533

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Paricalcitol
Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.
• 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.
• Atorvastatin
Atorvastatin: 20 mg/day oral (1 take) during 12 weeks

Locations

Country	Name	City	State
Spain	Hospital de León	León
Spain	Hospital El Bierzo. Servicio de Nefrología.	Ponferrada	(León).

Sponsors (1)

Lead Sponsor	Collaborator
Ricardo Mouzo Mirco

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Oxidative stress and inflammative parameters	Measure unit: IL-4	12 weeks of treatment
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Nutritional Parameters	Weight	12 weeks of treatment with visits and analysis
Secondary	Erythropoietin requirements variations	Fe	12 weeks of treatment with visits and analysis
Secondary	Assess potential benefits inflammatory markers	PTHi	12 weeks of treatment with visits and analysis
Secondary	Nutritional Parameters	Height	12 weeks of treatment with visits and analysis
Secondary	Nutritional Parameters	Body Mass Index (BMI)	12 weeks of treatment with visits and analysis
Secondary	Nutritional Parameters	Abdominal circumference	12 weeks of treatment with visits and analysis
Secondary	Nutritional Parameters	Triceps skin fold circumference	12 weeks of treatment with visits and analysis
Secondary	Nutritional Parameters	Bioimpedance	12 weeks of treatment with visits and analysis
Secondary	Anaemia parameters	Hemogram	12 weeks of treatment
Secondary	Anaemia Parameters	Biochemistry	12 weeks of treatment
Secondary	Erythropoietin requirement variations	Ferritin	12 weeks of treatment with visits and analysis
Secondary	Erythropoietin requirement variations	Transferrin saturation index	12 weeks of treatment with visits and analysis
Secondary	Erythropoietin requirements variations	B12	12 weeks of treatment with visits and analysis
Secondary	Erythropoietin requirements variations	Folic Acid	12 weeks of treatment with visits and analysis
Secondary	Assess potential benefits in inflammatory markers	Kt	16 weeks, the complete duration of the study