Trial record 20 of 52929 for:    Open Studies

Arterial Stiffness and Calcifications in Haemodialysis Patients on Sevelamer or Calcium Acetate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Romanian Society of Nephrology.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Liliana Garneata, Romanian Society of Nephrology
ClinicalTrials.gov Identifier:
NCT00364000
First received: August 10, 2006
Last updated: November 12, 2011
Last verified: November 2011
  Purpose

End-stage renal disease (ESRD) is a state of increased arterial stiffness of extensive vessel calcifications, compared with the non-renal population. Both arterial stiffness and arterial calcifications are potent predictors of all-cause and cardiovascular mortality in ESRD patients. Several studies have documented the direct relationship between the extent and severity of arterial/coronary calcifications and outcome in dialysis patients. The relationship is strong no matter if arterial calcifications were quantified by electron-beam computed tomography or a radiological calcification score. Calcifications are early and progressive events in these patients. PWV is strongly related to the degree of sonographic determined arterial calcifications and EBCT-derived coronary artery calcium score in chronic kidney disease patients.

Calcium-based phosphate binders are associated with progressive coronary artery and aortic calcification, especially when mineral metabolism is not well controlled.

According to recent studies, sevelamer hydrochloride is a potent non-calcium-containing phosphate binder, well tolerated in ESRD. Compared with calcium-based phosphate binders, sevelamer is less likely to cause hypercalcemia, low levels of PTH, and progressive coronary and aortic calcification in hemodialysis patients. Moreover, sevelamer has a favorable effect on the lipid profile.

Less is known about the relationship between sevelamer treatment and progression of arterial stiffness. To date, there is one single study examining the influence of sevelamer (versus calcium carbonate) on the evolution of arterial stiffness in a very small number (N=15) of haemodialysis patients. These study used the same patients as historical controls, thus being methodologically rather weak. Moreover, the follow-up was quite short - 6 month.

The aim of the trial is to to quantify, in a randomized opened-labeled controlled trial the effect of sevelamer hydrochloride on the evolution of arterial stiffness parameters (pulse wave velocity and the augmentation index) in chronic haemodialysis patients and to correlate these parameters with arterial calcification assessed by a previous described radiological score of arterial calcification and echocardiographic parameters (left ventricular hypertrophy, LV dilatation, systolic and diastolic dysfunction).


Condition Intervention
Haemodialyzed Patients
Hyperphosphatemia
Drug: Calcium acetate
Drug: Sevelamer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Arterial Stiffness and Arterial Calcifications Evolution in ESRD Haemodialysis Patients Treated by Sevelamer or Calcium Acetate

Resource links provided by NLM:


Further study details as provided by Romanian Society of Nephrology:

Primary Outcome Measures:
  • changes in arterial stiffness parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • changes in calcification score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • composite of all-cause mortality, cardiovascular mortality and major cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
Calcium acetate 670 mg tablets
Drug: Calcium acetate
Calcium acetate in 240 chronic HD patients
Experimental: II
label sevelamer (RenagelR) 800 mg tablets
Drug: Calcium acetate
Calcium acetate in 240 chronic HD patients
Drug: Sevelamer
label sevelamer (RenagelR) 800 mg tablets

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • more than 3 months on haemodialysis
  • willingness to participate
  • age 18-60 yrs
  • pre-dialysis blood pressure 120-160 mmHg in the last month prior to the initiation of study or recent (<1 Mo) addition of a new antihypertensive drug
  • iPTH at entry 200-800 pg/mL (as per severe hyperparathyroidism)
  • serum calcium at entry 2.2-2.6 mmol/L

Exclusion Criteria:

  • haemodynamic instability
  • uncontrolled hypertension
  • any severe, debilitating disease associated with a reduced survival
  • any major cardiovascular event in the last 12 month before study
  • cinacalcet therapy before study entrance
  • history of parathyroidectomy
  • documented history of poor compliance
  • serious gastrointestinal disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364000

Contacts
Contact: Gabriel Mircescu, Prof +40 722214504 gmircescu@hotmail.com
Contact: Ligia Petrescu, Md, PhD +40 722296287 ligiarares@yahoo.com

Locations
Romania
"Dr Carol Davila" Teaching Hospital of Nephrology Not yet recruiting
Bucharest, Romania, 010731
Contact: Ligia Petrescu, MD, PhD    +40 722296287    ligiarares@yahoo.com   
Contact: Simona Hildegard Stancu, MD, PhD    +40 723372069    shstancu@yahoo.com   
Sub-Investigator: Carmen Barbulescu, MD         
Sub-Investigator: Roxana Martinescu, MD         
Principal Investigator: Ligia Petrescu, MD, PhD         
Sub-Investigator: Simona Hildegard Stancu, MD, PhD         
"CI Parhon" Clinical Hospital Not yet recruiting
Iasi, Romania
Contact: Paul Gusbeth-Tatomir, MD    +40 720550384    paulgusbeth@yahoo.com   
Contact: Nicoleta Mardare, MD         
Principal Investigator: Paul Gusbeth-Tatomir, MD         
Sub-Investigator: Nicoleta Mardare, MD         
Sub-Investigator: Bogdan Alexandroaie, MD         
Sub-Investigator: Serban Ardeleanu, MD         
Sponsors and Collaborators
Romanian Society of Nephrology
Investigators
Study Director: Adrian Covic, Prof "CI Parhon" Clinical Hospital, Iasi
Study Director: Gabriel Mircescu, Prof "Dr Carol Davila" Teaching Hospital of Nephrology, Bucharest, Romania
  More Information

No publications provided

Responsible Party: Liliana Garneata, MD. PHD, Romanian Society of Nephrology
ClinicalTrials.gov Identifier: NCT00364000     History of Changes
Other Study ID Numbers: 02_2006
Study First Received: August 10, 2006
Last Updated: November 12, 2011
Health Authority: Romania: National Medicines Agency

Keywords provided by Romanian Society of Nephrology:
haemodialysis
hyperphosphatemia
sevelamer
calcium acetate

Additional relevant MeSH terms:
Calcinosis
Hyperphosphatemia
Calcium Metabolism Disorders
Metabolic Diseases
Phosphorus Metabolism Disorders
Calcium, Dietary
Sevelamer
Calcium acetate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014