Tissue-nonspecific Alkaline Phosphatase in Phosphate and Pyrophosphate Homeostasis.

NCT03520738 | Completed

• 1 other identifier: 17-AOIP-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

Vascular calcification is a common finding in chronic kidney disease and increases arterial stiffness leading to augmented cardiovascular morbidity. The calcification process is thoroughly regulated by pro and anticalcifying agents. The investigators hypothesize that imbalance in these compounds could depend on alkaline phosphatase activity. Therefore, the investigators will measure ALP activity, calcifications score, arterial stiffness and perform a bio-collection in monogenic rare diseases characterized by various levels of anticalcifying agents and in diverse CKD stages characterized by various levels of procalcifying compounds.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• ALP activity (alkaline phosphatase activity)

  ALP activity will be plotted against the PPi/Pi ratio in CKD patients with various Pi levels; a regression curve will be used to measure the correlation between these two factors

  at time = day 0 (inclusion)

Study Arms (3)

Chronic Kidney Disease

OTHER

Blood and urinary samples on the following patients: 10 Stage 1 and 2 CKD patients 10 patients 6 weeks after graft 10 patients on maintenance dialysis.

Other: Blood samples; Other: Urinary samples

Pseudoxanthoma elasticum (PXE)

OTHER

Blood and urinary samples on the following patients: 10 patients with pseudoxanthoma elasticum (PXE) with low PPi levels and vascular calcifications and patients with hypophosphatasia (HPP) with high PPi levels and bone decalcification.

Other: Blood samples; Other: Urinary samples

Hypophosphatasia (HPP)

OTHER

Blood and urinary samples on the following patients: 4 patients with hypophosphatasia (HPP) with high PPi levels and bone decalcification.

Other: Blood samples; Other: Urinary samples

Interventions

Blood samples OTHER

Blood samples on an empty stomach

Chronic Kidney Disease; Hypophosphatasia (HPP); Pseudoxanthoma elasticum (PXE)

Urinary samples OTHER

first urinary in the morning

Chronic Kidney Disease; Hypophosphatasia (HPP); Pseudoxanthoma elasticum (PXE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with Chronic kidney disease (stage 1 or 2, 6 weeks after graft or patients on maintenance dialysis) or patient with pseudoxanthoma elasticum or patient with hypophosphatasia
• informed consent signed

You may not qualify if:

• cancer
• pregnancy

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (4)

CHU d'Angers - Service de Dermatologie

Angers, France

Location

Service de Médecine Vacsulaire - CHU d'ANGERS

Angers, France

Location

CHU de Nice

Nice, France

Location

Service de Rhumatologie - Hôpital Cochin

Paris, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Guillaume FAVRE, MD

  Nephrology Department, Nice University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 11, 2018
• Study Start: May 15, 2018
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)