Crossover and randomized clinical trial on the effect of Resincolestiramine in the intestinal absorption of new uremic toxins in patients in hemodialysis with chronic renal insufficiency

Phase 1

• Conditions: Chronic renal insufficiency; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2017-001899-32-ES
• Lead Sponsor: Dr. Abelardo Aguilera Peralta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-02
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 58

Inclusion Criteria

•Patients who give their written consent to participate in the study.
•Men and women between 18 and 80 years
•Women of childbearing potential should use an effective contraceptive method (hormonal contraceptives, intrauterine device, condom) or refrain from having sex in order not to get pregnant. A woman is considered to be fertile after menarche and to become postmenopausal, unless she has undergone a permanent sterilization procedure (hysterectomy, salpingectomy, bilateral oophorectomy). A postmenopausal state is defined as absence of menstruation for 12 months without an alternative medical cause
•Adequate dialysis criteria according to the KDOQI guidelines: Target of spKt / V> 1.4 per hemodialysis session for patients treated three times per week
•Stable renal disease in the last 3 months. Chronic kidney disease is considered stable when it meets the following criteria:
-The associated chronic pathologies are adequately controlled and have not required hospitalization in the last 3 months.
-The patient has no hemodynamic changes (AT = 90/60 and = 160/90 mm Hg) outside the hemodialysis session.
-There are no signs of acute infection valued by the absence of leukocytosis in the blood count
-There is no clinical evidence of tumor pathology at the discretion of the investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Pregnant or lactating women.
•Total cholesterol values lower than 150 mg/dL with or without lipid-lowering treatment.
•Hemoglobin value =10 mg / dL (according to KDOQI guidelines).
•Serum PTH levels =750 pg / mL (moderate hyperparathyroidism).
•Prothrombin activity below 80% and / or treatment with acenocoumarol or warfarin
•Patients receiving Resincolestiramine on medical advice.
•Antecedents of autoimmune diseases and / or treatment with immunosuppressants
•Hypersensitivity to the active substance or to any of the excipients (carboxymethylcellulose, propylene glycol alginate, colloidal silica, sodium saccharin, sodium cyclamate, strawberry flavor)
•History of peptic ulcer
•Complete biliary obstruction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified