Chronic Renal Failure Clinical Trial
— SISMICOfficial title:
Symbiotics and Systemic Inflammation in Chronic Kidney Disease
Verified date | July 2022 |
Source | Centre Hospitalier Universitaire de Besancon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Main objective: To assess the effectiveness of treatment with symbiotics on the chronic systemic inflammation observed in chronic renal failure 4 months after the start of treatment.
Status | Recruiting |
Enrollment | 62 |
Est. completion date | November 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Men and women aged 18 to 80 inclusive - Women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches) - Signature of the informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study - Affiliation to a French social security scheme or beneficiary of such a scheme. - Patient with type II diabetes - Creatinine clearance less than 45 ml / min / 1.73m² - Serum CRPus level greater than 6 mg / l, evaluated twice from 15 days to 3 months apart - Patient not opposed to the conservation of biological samples for scientific research purposes. Exclusion Criteria: - Legal incapacity or limited legal capacity - Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator - Subject without health insurance - Pregnant woman - Subject being in the period of exclusion from another study or provided for by the "national file of volunteers". - Infectious episode with need for hospitalization less than 1 month old. - Active infection with hepatitis B and / or C virus. - Active or non-progressive infection with HIV. - Antibiotic therapy in the previous 3 months. - Anti-inflammatory treatment. - History of colectomy. - All chronic digestive pathologies. |
Country | Name | City | State |
---|---|---|---|
France | CHU de Besançon | Besançon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | inflammation | change in inflammation estimated by the serum CRP concentration <6 mg / L | 4 months | |
Secondary | inflammatory cytokines 1 | variation of IL-6 | At 2, 4 and 6 months after the start of treatment. | |
Secondary | inflammatory cytokines 2 | variation of IL-1ß | At 2, 4 and 6 months after the start of treatment. | |
Secondary | inflammatory cytokines 3 | variation of TNF-a | At 2, 4 and 6 months after the start of treatment. | |
Secondary | inflammatory cytokines 4 | variation of IL-10 | At 2, 4 and 6 months after the start of treatment. | |
Secondary | inflammatory cytokines 5 | variation of IL-8 | At 2, 4 and 6 months after the start of treatment. | |
Secondary | inflammatory cytokines 6 | variation of IFN? | At 2, 4 and 6 months after the start of treatment. | |
Secondary | inflammatory circulating monocytes | variation | At 2, 4 and 6 months after the start of treatment. | |
Secondary | intestinal microbial metabolome | modification of the intestinal microbial metabolome (Nuclear magnetic resonance) | At 2, 4 and 6 months after the start of treatment. | |
Secondary | intestinal membrane permeability | modification of LPS | At 2, 4 and 6 months after the start of treatment. | |
Secondary | bacterial translocation 1 | modification of CD14s | At 2, 4 and 6 months after the start of treatment. | |
Secondary | bacterial translocation 2 | modification of iFABP | At 2, 4 and 6 months after the start of treatment. | |
Secondary | health-related quality of life | SF-36 Health Survey (Short Form) The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | At 2, 4 and 6 months after the start of treatment. | |
Secondary | fragility | fragility (= 3 of the following 5 criteria: undernutrition, grip strength and walking speed, assessed exhaustion and physical activity) | At 2, 4 and 6 months after the start of treatment. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02565459 -
MSC and Kidney Transplant Tolerance (Phase A)
|
Phase 1 | |
Recruiting |
NCT01876017 -
Safety and Efficacy of BMMNC in Patients With Chronic Renal Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT02356419 -
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
|
Phase 1 | |
Withdrawn |
NCT03019159 -
Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis
|
N/A | |
Completed |
NCT02047006 -
Dose-finding of Rivaroxaban in Hemodialysis
|
Phase 4 | |
Completed |
NCT01617824 -
Rapid Effects Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT00828776 -
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure
|
Phase 2/Phase 3 | |
Completed |
NCT00597753 -
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
|
Phase 3 | |
Completed |
NCT00379899 -
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
|
Phase 4 | |
Terminated |
NCT00372489 -
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD
|
Phase 2 | |
Completed |
NCT00228436 -
Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients
|
Phase 2 | |
Completed |
NCT03772171 -
Estimate for Dietary Intakes and Hemodialysis Patients
|
||
Recruiting |
NCT02586402 -
Safety & Efficacy of Pegolsihematide for Treatment of Anemia in Participants on Dialysis
|
Phase 2 | |
Completed |
NCT01879618 -
Use Of Fragmin In Hemodialysis
|
Phase 3 | |
Not yet recruiting |
NCT01346215 -
Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
|
Phase 3 | |
Completed |
NCT01220843 -
FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease
|
Phase 3 | |
Completed |
NCT01111630 -
Study of Erythropoietin (EPO) Administration Schedule
|
Phase 4 | |
Completed |
NCT00742716 -
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
|
Phase 2 | |
Completed |
NCT00597584 -
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
|
Phase 3 | |
Completed |
NCT00598273 -
Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
|
Phase 3 |