An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients

Status unconfirmed · Phase 2

Conditions studied: Hyperphosphatemia, Inflammation, Renal Disease

In brief

The purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dialysis.

Key facts

Study ID

NCT00834301

Run by

Nephrian

People needed

25

Starts

2009-01-01

Expected to finish

2009-09-01

Last updated by the study team

2009-02-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• End stage renal disease patients on dialysis for at least 90 days deemed to be at low risk by the investigator for being hospitalized or have concurrent infections
• Serum phosphorous level > 5 mg/dl
• Stable phosphate binder regimen for 2 week prior to enrollment
• Stable dose of Vitamin D for 4 weeks prior to enrollment
• Stable calcimimetic dose for 4 week prior to enrollment

You may not qualify if…

• patients who are pregnant
• patients who have pre existing thrombocytopenia defined as a platelet count of <100 x 109/L
• abnormal LFTs
• baseline CRP > 15 g/dl
• known sensitivity to any of the active ingredients
• patients who are currently enrolled in a clinical trial, or who have been in a clinical trial in the last six months
• are currently taking any immunosuppressive medications

Where it is running

• Simi Valley Dialysis Center — Simi Valley, California, United States (enrolling)

Full record on ClinicalTrials.gov

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