Pharmacoepidemiological Study of Secondary Hyperparathyroidism in Lorraine

NCT02888639 | Completed DMC

• 1 other identifier: EPHEYL
• Study Type: observational
• Target: 305
• Locations: 0 countries
• Sites: N/A

Brief Summary

The pharmacoepidemiological EPHEYL (Étude PHarmacoÉpidémiologique de l'hYperparathyroïdie secondaire en Lorraine) study is a 2-year, open-cohort, prospective, observational study on incident SHPT, i.e. newly diagnosed, with a 2 year follow-up, set in the 12 dialysis units located in the French region of Lorraine (public or private).

Conditions

ESRD

Outcome Measures

Primary Outcomes (1)

• Parathormone level

  Obtaining the therapeutic target according to the K/DOQI

  2 years

Secondary Outcomes (9)

• Phosphocalcium product level

  2 years

• Serum calcium level

  2 years

• Serum phosphorus level

  2 years

• Symptoms and / or clinical events caused by hyperparathyroidism

  2 years

• Tolerance of therapeutic interventions: nausea, vomiting, diarrhea, hypocalcemia

  2 years

Eligibility Criteria

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

Study Population

ESRD requiring mainteance dialysis

You may qualify if:

• age \>= 18 years
• Patient on hemodialysis or peritoneal dialysis for 3 months or more in one of the 12 dialysis units in the study.
• Patient included in the REIN registry in the Lorraine region.
• Parathormone greater than or equal to 500 pg / ml for the first time after 01/04/2009 (patient incident for secondary hyperparathyroidism).

You may not qualify if:

• age \< 18 years.
• Patient living in Lorraine but dialysed in a unit outside Lorraine.
• Diagnosis of secondary hyperparathyroidism with higher parathormone or equal to 500 pg / ml placed before 1/4/2009.
• Patient who have received medical treatment with cinacalcet or by surgical parathyroidectomy for secondary hyperparathyroidism.
• Patient expressing opposition to the collection of information.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (1)

• Filipozzi P, Ayav C, Ngueyon Sime W, Laurain E, Kessler M, Brunaud L, Frimat L. Trajectories of CKD-MBD biochemical parameters over a 2-year period following diagnosis of secondary hyperparathyroidism: a pharmacoepidemiological study. BMJ Open. 2017 Mar 27;7(3):e011482. doi: 10.1136/bmjopen-2016-011482.

  PMID: 28348181 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

Study Officials

• Luc Frimat, MD, PhD

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 5, 2016
• Study Start: December 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 5, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share