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Treatment Modification to Reduce Symptom Burden in Hemodialysis

This study has been completed.
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute Identifier:
First received: January 16, 2013
Last updated: February 26, 2016
Last verified: February 2016
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.

Condition Intervention
End Stage Renal Disease Other: Treatment modification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Modification and Symptom Burden in High-Risk Dialysis Patients

Further study details as provided by The Rogosin Institute:

Primary Outcome Measures:
  • quality of life [ Time Frame: 6 weeks ]
    Symptoms and quality of life as measured by the Short Form-36 and Dialysis Symptom Index

Enrollment: 16
Study Start Date: January 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment modification
Patients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus.
Other: Treatment modification
No Intervention: Usual care
Patients will receive the usual hemodialysis care with no modifications


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • hemodialysis patient
  • transplant ineligible

Exclusion Criteria:

  • dementia
  • unable to answer questionnaires for any reason
  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 identifier: NCT01775800

United States, New York
The Rogosin Institute
New York, New York, United States, 10021
Sponsors and Collaborators
The Rogosin Institute
Weill Medical College of Cornell University
Principal Investigator: Nathaniel Berman, M.D. The Rogosin Institute
  More Information

Responsible Party: The Rogosin Institute Identifier: NCT01775800     History of Changes
Other Study ID Numbers: 1207012494
Study First Received: January 16, 2013
Last Updated: February 26, 2016

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases processed this record on September 21, 2017