NCT00124969

Brief Summary

Patients with end-stage renal failure have a markedly higher mortality because of cardiovascular events in comparison with the normal population. Disorders in the calcium metabolism, such as calcification of the vessel walls, occur very frequently. There are indications that calcium channel blockers are capable of lowering the cardiovascular mortality in patients with end-stage renal failure. It is intended to carry out a prospective, randomized, double-blind, placebo-controlled, multicenter study in order to find out if the calcium channel blocker amlodipine is able to reduce the mortality of patients with end-stage renal failure. The investigation will be carried out after suitable explanation and written informed consent in 356 patients aged between 18 and 90 years with end-stage renal failure and chronic haemodialysis treatment. The patients will be randomized to either treatment with amlodipine 10 mg/day or placebo. The occurrence of events will be documented and evaluated prospectively over a period of 30 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 29, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

May 9, 2008

Status Verified

October 1, 2006

First QC Date

June 30, 2005

Last Update Submit

May 7, 2008

Conditions

Kidney Failure, Chronic

Keywords

End-stage renal disease, hemodialysis

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be the survival rate. The secondary outcome will be cardiovascular events.

    Prospective: look forward using periodic observations collected predominantly following subject enrollment

Study Arms (2)

1

ACTIVE COMPARATOR

Amlodipine

Drug: Amlodipine

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AmlodipineDRUG

10mg

Also known as: Placebo
1
PlaceboDRUG

10mg

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End-stage renal disease
  • Hemodialysis
  • Hypertension
  • Written informed consent

You may not qualify if:

  • Hypotension of less than 90 mmHg systolic
  • High-grade aortic stenosis
  • Heart failure of NYHA stage III and IV
  • Acute myocardial infarction (within the last 4 weeks)
  • Acute heart failure
  • Known allergy to the medicament amlodipine or other constituents of the medicament
  • Severe disorders of liver function
  • Pregnancy and breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Related Publications (3)

  • Tepel M, Giet MV, Park A, Zidek W. Association of calcium channel blockers and mortality in haemodialysis patients. Clin Sci (Lond). 2002 Nov;103(5):511-5. doi: 10.1042/cs1030511.

    PMID: 12401125BACKGROUND

  • Mugendi GA, Mutua FM, Natale P, Esterhuizen TM, Strippoli GF. Calcium channel blockers for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 Oct 1;10(10):CD011064. doi: 10.1002/14651858.CD011064.pub2.

    PMID: 33000470DERIVED

  • Tepel M, Hopfenmueller W, Scholze A, Maier A, Zidek W. Effect of amlodipine on cardiovascular events in hypertensive haemodialysis patients. Nephrol Dial Transplant. 2008 Nov;23(11):3605-12. doi: 10.1093/ndt/gfn304. Epub 2008 May 29.

    PMID: 18511605DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Martin Tepel, Dr

    Charite Campus Benjamin Franklin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 29, 2005

Study Start

January 1, 2002

Study Completion

October 1, 2006

Last Updated

May 9, 2008

Record last verified: 2006-10

Locations

DE(1)