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A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD

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. Identifier: NCT00785629
Recruitment Status : Completed
First Posted : November 5, 2008
Results First Posted : October 30, 2012
Last Update Posted : October 30, 2012
Fresenius Medical Care North America
Genzyme, a Sanofi Company
Novartis Pharmaceuticals
DaVita Dialysis
Information provided by (Responsible Party):
Denver Nephrologists, P.C.

Brief Summary:
The purpose of this study is to determine the ability of 3 commercially available phosphorus binders (calcium acetate, sevelamer carbonate, and lanthanum carbonate) to achieve and maintain a phosphorus level in the normal range in patients with chronic kidney disease.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Calcium acetate Drug: Lanthanum Carbonate Drug: Sevelamer Carbonate Drug: Placebo Not Applicable

Detailed Description:
It is the specific aim of this pilot study to assess the feasibility of achieving and maintaining a serum P less than or equal to 3.5 mg/dL (1.13 mmol/L) in patients with eGFR >20 and <45 mL/min with any of the 3 commercially available P lowering agents (calcium acetate, sevelamer carbonate, or lanthanum carbonate). Results of this study will clarify the degree of separation in serum P that can be achieved with the use of P lowering agents and the current standard of care (P binder initiation when P > 5.5 mg/dL or 1.78 mmol/L). Furthermore, this knowledge, combined with analyses of the secondary aims and outcomes of interest, will serve to facilitate the design of a properly powered, randomized, placebo controlled clinical outcomes trial that will firmly establish the necessity of achieving a specific target P in patients with CKD. The secondary aims of this pilot study are to provide insight into the optimal detection of progression of abnormalities in mineral metabolism and their relationship to vascular disease in CKD. The tertiary aim is to evaluate long term outcomes related to phosphorus normalization with respect to renal replacement therapy or death.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double Blind Randomized Placebo Controlled Trial of Maintenance of Normal Serum Phosphorus in Chronic Kidney Disease (CKD)
Study Start Date : February 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: Calcium Acetate
667 mg with meals
Drug: Calcium acetate
Active Comparator: Lanthanum Carbonate
500 mg with meals
Drug: Lanthanum Carbonate
Other Name: Fosrenol

Active Comparator: Sevelamer Carbonate
800 mg with meals
Drug: Sevelamer Carbonate
Other Name: Renvela

Placebo Comparator: Placebo
with meals
Drug: Placebo

Primary Outcome Measures :
  1. Serum Phosphorus [ Time Frame: months 3-9 ]
    mean serum phosphorus from months 3-9

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men or women > 18 years of age;
  • Has signed and dated the most recent informed consent form approved by an IRB;
  • Will, in the opinion of the PI, be compliant with prescribed phosphate binder therapy;
  • Must be able to communicate with the investigator, and be able to understand and comply with the requirements of the study;
  • Has a life expectancy >12 months;
  • An eGFR rate (estimated by the MDRD equation) ≥ 20 and ≤ 45 mL/min/1.73m2 obtained by screening laboratory values and in the opinion of the investigator felt to have CKD without evidence of recent acute kidney injury or unexpected decline in renal function;
  • A screening serum phosphorus value > 3.5 mg/dL and ≤ 6.0 mg/dL;
  • Must consume a minimum of 2 meals per day and be willing to avoid intentional changes in diet;
  • Women of child bearing potential must be practicing an acceptable form of birth control.

Exclusion Criteria:

  • Receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to baseline;
  • Subject is pregnant, is breast feeding or is of child bearing potential and not using acceptable birth control measures;
  • Has had a previous renal transplant;
  • Has a chronic reliance on enemas or laxatives;
  • Has a known sensitivity or previous intolerance to any of the products to be administered during the study;
  • Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin;
  • Currently has an active infection or is being treated with antibiotics (within 14 days prior to baseline);
  • Has been hospitalized within 30 days prior to baseline (with the exception of hospitalizations due to vascular access procedures);
  • Any surgical or medical condition which might significantly alter the function of phosphorus binders or which may jeopardize the subject in case of participation in the study. The investigator should be guided by evidence of any of the following: Severe gastrointestinal motility disorder,Bowel obstruction,Dysphagia or other disorders of swallowing, Acute peptic ulcer, Ulcerative colitis or Crohn's disease, History of major gastrointestinal tract surgery, Severe malabsorption;
  • Currently taking any of the following within 14 days prior to baseline; Calcitriol or its analogs, Cinacalcet hydrochloride, Medications prescribed for the purpose of phosphorus binding;
  • Screening serum intact PTH >500 pg/mL;
  • Screening corrected calcium < 8.0 mg/dL or > 10.4 mg/dL;
  • Uncontrolled hyperlipidemia in the opinion of the PI;
  • Initiation of chronic maintenance hemodialysis planned within 12 months;
  • Relocation to another area planned within 12 months;
  • Has a known history of immunodeficiency diseases, including a positive HIV test result;
  • Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12 months prior to dosing or evidence of such abuse;
  • Evidence of active liver disease with AST or ALT levels greater than 3X the upper limit of normal;
  • Has had a major cardiovascular event within 180 days of screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00785629

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United States, Colorado
Denver Nephrologists, PC
Denver, Colorado, United States, 80230
Sponsors and Collaborators
Denver Nephrologists, P.C.
Fresenius Medical Care North America
Genzyme, a Sanofi Company
Novartis Pharmaceuticals
DaVita Dialysis
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Principal Investigator: Geoffrey A Block, MD Denver Nephrologists, PC
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Denver Nephrologists, P.C. Identifier: NCT00785629    
Other Study ID Numbers: PNT001
First Posted: November 5, 2008    Key Record Dates
Results First Posted: October 30, 2012
Last Update Posted: October 30, 2012
Last Verified: September 2012
Keywords provided by Denver Nephrologists, P.C.:
secondary hyperparathyroidism
vascular calcification
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Calcium acetate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action