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

This study has been completed.
Sponsor:
Collaborators:
Shire
Fresenius Medical Care North America
Genzyme, a Sanofi Company
Novartis Pharmaceuticals
DaVita Dialysis
Information provided by (Responsible Party):
Denver Nephrologists, P.C.
ClinicalTrials.gov Identifier:
NCT00785629
First received: November 4, 2008
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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 Intervention
Chronic Kidney Disease
Drug: Calcium acetate
Drug: Lanthanum Carbonate
Drug: Sevelamer Carbonate
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Denver Nephrologists, P.C.:

Primary Outcome Measures:
  • Serum Phosphorus [ Time Frame: months 3-9 ] [ Designated as safety issue: Yes ]
    mean serum phosphorus from months 3-9


Enrollment: 148
Study Start Date: February 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00785629

Locations
United States, Colorado
Denver Nephrologists, PC
Denver, Colorado, United States, 80230
Sponsors and Collaborators
Denver Nephrologists, P.C.
Shire
Fresenius Medical Care North America
Genzyme, a Sanofi Company
Novartis Pharmaceuticals
DaVita Dialysis
Investigators
Principal Investigator: Geoffrey A Block, MD Denver Nephrologists, PC
  More Information

No publications provided

Responsible Party: Denver Nephrologists, P.C.
ClinicalTrials.gov Identifier: NCT00785629     History of Changes
Other Study ID Numbers: PNT001
Study First Received: November 4, 2008
Results First Received: August 27, 2012
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Denver Nephrologists, P.C.:
phosphorus
secondary hyperparathyroidism
vascular calcification

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Sevelamer
Calcium acetate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014