Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2015-000619-42-ES
EUCTR2015-000619-42-ES
Active, not recruiting
Phase 1

An open, Phase II, clinical trial to evaluate the effectiveness of decreased intestinal absorption of phosphorus in the progression of renal disease in patients with metabolic syndrome

FIBICO0 sites99 target enrollmentMarch 3, 2015
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsChronic kidney disease and metabolic syndromeTherapeutic area: Not possible to specify
DrugsFosrenol

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic kidney disease and metabolic syndrome
Sponsor
FIBICO
Enrollment
99
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 3, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FIBICO

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients who have previously participated in the study entitled Influence of phosphorus excretion on the progression of renal damage: Mechanisms and clinical studies and belonging to the group formed by tertile 2 \+ 3, according to the ratio between urinary excretion of phosphorus and creatinine (P / Cr).
  • •2\. Subjects of both sexes with age range between 18 and 85 years.
  • •3\. Patients with metabolic syndrome, defined by the presence of three or more of the diagnostic criteria established in the Joint Interim Statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity (Alberti et al Circulation 2009; 120:.. 1640\-1645\):
  • •(1\) high waist circumference (women ?88 cm, man ?102 cm)
  • •(2\) elevated triglycerides (?150 mg / dL) or use of specific medication
  • •(3\) reduced HDL (men \<40 mg / dL, women \<50 mg / dL) or use of specific medication
  • •(4\) impaired fasting glucose (?100 mg / dL) or use of antidiabetic medication
  • •(5\) hypertension (systolic blood pressure ?130 or diastolic ?85 mm Hg or respectively) or use of antihypertensive medication.
  • •4\. Glomerular filtration rate estimated by the formula CKD\-EPI, between 30 and 90 ml / min / 1\.73m2\. (stages 2 and 3 of the classification of chronic kidney disease)
  • •5\. Patient able to understand the study procedures and granted their informed consent trial participation.

Exclusion Criteria

  • •1\. hyperphosphataemic defined as phosphorus concentration greater than 5 mg / dl.
  • •2\. Patients with clinical signs of congestive heart failure.
  • •3\. Active infections within 30 days prior to baseline.
  • •4\. Patients with systemic inflammatory disease.
  • •5\. HIV infection, Hepatitis C and Hepatitis B.
  • •6\. History of cancer within the previous five years.
  • •7\. Chronic liver disease.
  • •8\. immunosuppressive therapy.
  • •9\. Pregnant women, breastfeeding, or planning to become pregnant.
  • •10\. Addiction to drugs or alcohol in the investigator's opinion, may interfere with the fulfillment of study requirements.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Not Applicable
A phase 1/2a, open-label trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of intrathecally administered VO659 in participants with spinocerebellar ataxia types 1, 3 and Huntington*s diseasea group of rare, inherited, genetic disorders that affect specific parts of the brain, including the cerebellum (the center of motor coordination), brain stem and spinal cord. These disorders can cause problems such as problems with balance, coordination, walking, swallowing and speaking.Huntingtons DiseaseSpinocerebellar ataxia10029299
NL-OMON53759VICO Therapeutics B.V.20
Active, not recruiting
Phase 1
A first-in-human trial to test how safe a new drug called VO659 is for people with genetic disorders called spinocerebellar ataxia type 1, 3 or Huntington’s disease
EUCTR2022-001314-19-ITVICO Therapeutics B.V.95
Active, not recruiting
Phase 1
A first-in-human trial to test how safe a new drug called VO659 is for people with genetic disorders called spinocerebellar ataxia type 1, 3 or Huntington’s diseasespinocerebellar ataxia types 1, 3 and Huntington’s diseaseMedDRA version: 23.0Level: LLTClassification code 10057660Term: Spinocerebellar ataxiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 20.0Level: PTClassification code 10070668Term: Huntington's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2022-001314-19-DKVICO Therapeutics B.V.95
Active, not recruiting
Phase 1
A first-in-human trial to test how safe a new drug called VO659 is for people with genetic disorders called spinocerebellar ataxia type 1, 3 or Huntington’s disease
EUCTR2022-001314-19-DEVICO Therapeutics B.V.95
Active, not recruiting
Phase 1
ABORL - A Phase II trial aiming to evaluate the clinical interest of ABEMACICLIB in patients with locally advanced/metastatic head and neck cancer harboring an homozygous deletion of CDKN2A, and/or an amplification of CCND1 and/or of CDK6 refractory to standards treatmentsPatients with locally advanced/metastatic head and neck cancer after failure of platinum and cetuximab or anti-EGFR-basedMedDRA version: 20.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2016-004537-25-FRCentre Léon Bérard25