Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism)

NCT01452100 | Terminated Phase 2 DMC

• 2 other identifiers: 10037012010-021467-33
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Cholesterol cristal embolization (CCE) is an orphan multisystem vascular condition occurring in elderly with severe atherosclerosis. In most patients, avoiding the precipitating factors and combination of statin and RAS inhibitor are recommended. The lack of randomized controlled trial in CCE precludes significant advances. The investigators decided to assess whether prednisone started early, at mild dosage and for a short period prevents death and progression to end-stage renal failure in patients with severe CCE, as compared to placebo.

Conditions

Cholesterol Embolism Systemic

Keywords

embolism; cholesterol cristal; creatinine; renal insufficiency; prednisone; systemic atheroembolism

Outcome Measures

Primary Outcomes (1)

• 1-year survival and 1-year renal survival (composite criteria)

  1 year

Secondary Outcomes (4)

• Number and duration of hospitalization(s)

  1 year

• course of renal function

  1 year

• number of cardiovascular events

  1 year

• prednisone tolerance

  1 year

Study Arms (2)

prednisone

EXPERIMENTAL

• Patients enrolled into the study will be treated with prednisone, 20 mg/day (if body weight \<70 kg ; or 25mg/d if body weight \>70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).

Drug: prednisone

placebo

PLACEBO COMPARATOR

Patients enrolled into the study will be treated with placebo, 20 mg/day (if body weight \<70 kg ; or 25mg/d if body weight \>70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).

Other: placebo

Interventions

prednisone DRUG

Patients enrolled into the study will be treated with prednisone, 20 mg/day (if body weight \<70 kg ; or 25mg/d if body weight \>70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).

Also known as: Cortancyl

prednisone

placebo OTHER

• Patients enrolled into the study will be treated with placebo, 20 mg/day (if body weight \<70 kg ; or 25mg/d if body weight \>70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).

placebo

Eligibility Criteria

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

You may qualify if:

• Biopsy-proven CCE or clinically diagnosed CCE as assessed on the 3 following criteria : presence of one or more precipitating factors renal function deterioration in atherosclerotic patients ischemic changes of the extremities or demonstration of retinal embolism
• Severe CCE as defined by either acute renal failure (S creatinine \> 125 micromol/l and increase \> 25 % of baseline), or severe abdominal changes (hemorrhage, infarction, perforation or weight loss \> 5 % of body weight) or severe central nervous system neurological complication

You may not qualify if:

• CCE unproven, or restricted to one organ, or non-active contraindication to prednisone.

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Ministry of Health, France: collaborator

Study Sites (1)

CHU Toulouse service néphrologie

Toulouse, Toulouse, 31052, France

Location

MeSH Terms

Conditions

Embolism; Renal Insufficiency

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dominique Chauveau, PhD

  University Hospital, Toulouse

  STUDY DIRECTOR

• Antoine Huart, MPD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: October 14, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)