Recruiting
Phase 2

Renal Multivitamin

Sponsor:

Nephrian

Code:

NCT00834301

Conditions

Hyperphosphatemia

Inflammation

Renal Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Oral Multivitamin

Study Details

Brief summary:

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.

Conditions

Hyperphosphatemia

Inflammation

Renal Disease

Study ID

NCT00834301

Start date

Jan, 2009

Status verified date

Feb, 2009

Completion date

Sep, 2009

Anticipated

Primary completion date

Sep, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

Interventions

Oral Multivitamin

Oral Multivitamin

Primary outcome measure

  • To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population. [ Time Frame: 8 weeks ]

Central Contacts and Locations

Locations

Simi Valley Dialysis Center

Recruiting

Simi Valley, California, United States, 93063

Contacts

Kant Tucker, MD

805-433-7500

Principal Investigator:

Kant Tucker, MD

More Information

Sponsor

Nephrian

Last update posted

Feb 3, 2009

Last verified

Feb, 2009

Keywords

  • End Stage Renal Disease
  • Inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nephrian on 2009-02-03.