Chronic renal insufficiency
Conditions
Interventions
Trade Name: Resincolestiramina
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: COLESTYRAMINE
Current Sponsor code: Resincolestirami
Sponsors
Dr. Abelardo Aguilera Peralta
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to quantify the effect on serum concentrations of phenols and indoles and AGEs, after administration of Resincolestiramine in patients with chronic renal failure in hemodialysis.; Secondary Objective: •To characterize the profile of blood lipoproteins using the Liposcale test. •To evaluate the effect of the treatment on the different parameters obtained by the Liposcale test. •To characterize the blood glycoprotein profile using Nuclear Magnetic Resonance. •To evaluate the effect of the treatment on the different parameters obtained through the characterization of blood glycoproteins. •To Evaluate the degree of association between the variables obtained by NMR and the quantification of AGEs •To quantify the variation in serum levels of CML, TNF-?, IL-6 and Protein C Reactive after treatment •To study the safety of treatment ;Primary end point(s): Percentage reduction in the serum concentration of phenols and indols and AGEs after treatment with Resincolestiramine during 3 months with respect to the 3-month period without treatment.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Complete profile of blood lipoproteins using the Liposcale test. The test allows to determine the size and concentration of particles and lipids of the main lipoprotein fractions (VLDL, LDL and HDL) as well as the particle concentration of a total of nine lipoprotein subfractions: -The lipid combination: Cholesterol and Triglycerides of each fraction (VLDL-C, VLDL-TG, IDL-C, LDL-TG, HDL-C and HDL-TG) - Average size of particles of each main fraction (VLDL-Z, LDL-Z and HDL-Z). (Total, large VLDL-P, medium VLDL-P, small VLDL-P), LDL (total, large LDL-P, LDL-P median, LDL-P) and HDL Medium, small HDL-P). ?Profiling of blood glycoproteins by Nuclear Magnetic Resonance (NMR). ? Serum levels of TNF-?, IL-6 and Protein C Reactive. ?Number of adverse events in patients with chronic renal failure on hemodialysis under treatment with Resincolestiramine ;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Spain
Contacts
Public ContactCoordinación de ensayos clínicos
Gina Paola Mejía Abril
Outcome results
None listed