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Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191762
First Posted: August 31, 2010
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Kenneth R. Phelps, M.D., Phelps, Kenneth R., M.D.
Results First Submitted: November 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Hyperparathyroidism
Chronic Kidney Disease
Interventions: Drug: sevelamer carbonate
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with eGFR < 60 were recruited from renal clinics and randomized to receive 3 tablets of sevelamer or placebo with each meal for four weeks.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was preceded by a 4-week course of vitamin D (dose determined by plasma [25OHD]) and then by a 4-week period of dietary phosphate restriction. The phosphate restriction was continued through the therapeutic trial.

Reporting Groups
  Description
Sevelamer Carbonate

2400 mg (3 pills) with each meal

sevelamer carbonate : 2400 mg with each meal for 4 weeks

Placebo Control

3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.

placebo : 3 tablets with each meal


Participant Flow:   Overall Study
    Sevelamer Carbonate   Placebo Control
STARTED   15   15 
COMPLETED   14 [1]   15 
NOT COMPLETED   1   0 
Adverse Event                1                0 
[1] One subject dropped out on the 3rd treatment day because of gastrointestinal complaints.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Post-treatment data were not obtained from patient who withdrew on third treatment day.

Reporting Groups
  Description
Sevelamer Carbonate

2400 mg (3 pills) with each meal

sevelamer carbonate : 2400 mg with each meal for 4 weeks

Placebo Control

3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.

placebo : 3 tablets with each meal

Total Total of all reporting groups

Baseline Measures
   Sevelamer Carbonate   Placebo Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   15   29 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   3   6   9 
>=65 years   11   9   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.7  (8.5)   70.1  (10.5)   71.8  (9.6) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   14   15   29 
Region of Enrollment 
[Units: Participants]
     
United States   14   15   29 


  Outcome Measures

1.  Primary:   Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
All intended measurements were made. The desired number of participants was recruited.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kenneth R. Phelps, M.D.
Organization: Kenneth R. Phelps, M.D.
phone: 518-626-5641
e-mail: kenneth.phelps@va.gov


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kenneth R. Phelps, M.D., Phelps, Kenneth R., M.D.
ClinicalTrials.gov Identifier: NCT01191762     History of Changes
Other Study ID Numbers: PhelpsK
First Submitted: August 27, 2010
First Posted: August 31, 2010
Results First Submitted: November 13, 2013
Results First Posted: July 31, 2014
Last Update Posted: November 1, 2016