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OpenTrials
Completed

NCT Number: NCT01775800

Treatment Modification to Reduce Symptom Burden in Hemodialysis

Many patients on hemodialysis experience high rates of symptom burden, such as pain, depression, anxiety and difficulty breathing. This study seeks to reduce these symptoms by modifying the usual guidelines used to manage patients on hemodialysis. For example, rather than trying to keep serum phosphorus below 5.5, patients enrolled in this study may have treatment goals of less than 6.5, in order to reduce the number of pills they need to take and potentially reduce harmful side effects. Blood pressure and serum parathyroid hormone goals will also be modified, to see if these modifications help hemodialysis patients feel better.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rogosin Institute

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hemodialysis patient
  • transplant ineligible

Exclusion criteria

  • dementia
  • unable to answer questionnaires for any reason

Treatment and study plan

Treatment modification

Other

Primary outcomes

  1. Number of Participants Recruited, Consented, Randomized and Completed

    Time frame: Each participant was assessed for 6 weeks; total recruitment period was 15 months

Secondary outcomes

  1. Symptom Burden

    Time frame: Baseline and 6 weeks

    Number of symptoms in past week as measured by the Dialysis Symptom Index

Sponsors and collaborators

Lead sponsor

The Rogosin Institute

Other

Collaborators

  • Weill Medical College of Cornell University

Registry information

Official study title

Treatment Modification and Symptom Burden in High-Risk Dialysis Patients

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 25, 2013
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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