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

Ricardo Mouzo Mirco

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: Paricalcitol, atorvastatin; Drug: Atorvastatin; Drug: Paricalcitol

Study type: Interventional

Funder types: Other

Identifiers

NCT01820767

SENPARIC-2011-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 3 patient groups

Paricalcitol

Experimental group

Description:

SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week.

Treatment:

Drug: Paricalcitol

Paricalcitol, Atorvastatin

Active Comparator group

Description:

SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg)

Treatment:

Drug: Paricalcitol, atorvastatin

Atorvastatin

Active Comparator group

Description:

SUBGROUP 3 (G3): Atorvastatin (same G2 dosis)

Treatment:

Drug: Atorvastatin