Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease

NCT00438932 | Completed Results DMC

• 1 other identifier: 2005P000486
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about how the kidneys control the blood levels of phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.

Conditions

Chronic Kidney Disease

Keywords

phosphate, phosphorus, FGF-23, PTH, 1,25D

Outcome Measures

Primary Outcomes (1)

• Fibroblast Growth Factor 23 (FGF-23)

  Plasma FGF-23 was measured using c-terminal FGF23 assay.

  2 weeks

Secondary Outcomes (1)

• 24-hour Urinary Phosphate

  2 weeks

Study Arms (4)

Lanthanum Carbonate and Low Phosphorus Diet

ACTIVE COMPARATOR

25% of subjects will receive binders plus a phosphate restricted diet.

Drug: Lanthanum Carbonate; Dietary Supplement: Low Phosphorus Diet

Lanthanum Carbonate and Unrestricted Phosphorus Diet

ACTIVE COMPARATOR

25% binders + unrestricted phosphate diet.

Drug: Lanthanum Carbonate; Dietary Supplement: Unrestricted Phosphorus Diet

Placebo and Low Phosphorus Diet

ACTIVE COMPARATOR

25% placebo + phosphate restricted diet.

Dietary Supplement: Low Phosphorus Diet; Drug: Placebo

Placebo and Unrestricted Phosphorus Diet

ACTIVE COMPARATOR

25% placebo + unrestricted phosphate diet.

Dietary Supplement: Unrestricted Phosphorus Diet; Drug: Placebo

Interventions

Lanthanum Carbonate DRUG

Lanthanum carbonate 1000mg 3x/day

Lanthanum Carbonate and Low Phosphorus Diet; Lanthanum Carbonate and Unrestricted Phosphorus Diet

Low Phosphorus Diet DIETARY_SUPPLEMENT

Low phosphorus diet will consist of 800 mg of phosphorus per day.

Lanthanum Carbonate and Low Phosphorus Diet; Placebo and Low Phosphorus Diet

Unrestricted Phosphorus Diet DIETARY_SUPPLEMENT

Unrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.

Also known as: Neutraphos

Lanthanum Carbonate and Unrestricted Phosphorus Diet; Placebo and Unrestricted Phosphorus Diet

Placebo DRUG

Lanthanum Carbonate placebo given three times a day with meals.

Placebo and Low Phosphorus Diet; Placebo and Unrestricted Phosphorus Diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects with stage 3a, 3b and 4 CKD
• subjects have to be aged 18 years or older
• subjects have to have normal serum phosphate levels (\< 4.6 mg/dl)
• subjects have to have sufficient 25-OH Vit0amin D levels (≥ 20 ng/ml)

You may not qualify if:

• subjects with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
• subjects expected to require dialysis initiation within the follow up period
• subjects with hyperphosphatemia \> 4.6 mg/dL
• subjects with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
• subjects with malnutrition, defined as a serum albumin \< 3.0 mg/dl, in order to avoid worsening protein-malnutrition status during the restricted study period since phosphate restricted diets are also low in protein
• subjects with chronic gastrointestinal diseases that could impede their absorptive ability such as Crohn's disease, ulcerative colitis and sprue
• subjects with liver disease (ALT or AST \> 100 U/L) or cholestasis (direct bilirubin \> 1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such as vitamin D
• subjects with anemia, defined as a hematocrit \<27% at the screening visit
• subjects wht have been hospitalization within the previous 4 weeks
• subjects who are pregnant
• subjects who are breastfeeding mothers
• subjects with primary hypoparathyroidism
• subjects with primary hyperparathyroidism
• subjects with previous subtotal parathyroidectomy
• subjects with previous outpatient counseling by a renal nutritionist

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Shire: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Isakova T, Gutierrez OM, Smith K, Epstein M, Keating LK, Juppner H, Wolf M. Pilot study of dietary phosphorus restriction and phosphorus binders to target fibroblast growth factor 23 in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Feb;26(2):584-91. doi: 10.1093/ndt/gfq419. Epub 2010 Jul 14.

  PMID: 20631407 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

In addition to limited power, the small sample size led to imbalances in baseline laboratory tests, which added further variability to the analyses. .

Results Point of Contact

• Title: Tamara Isakova, MD, MMSc
• Organization: University of Miami Miller School of Medicine

tisakova@med.miami.edu

305-243-4374

Study Officials

• Myles Wolf, MD, MMSc

  Univesity of Miami Miller School of Medicine

  PRINCIPAL INVESTIGATOR

• Harald Jueppner, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 22, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 27, 2011
• Results First Posted: September 27, 2011

Record last verified: 2011-09

Locations

US (1)