Survey on Anemia Therapy in Participants With Chronic Kidney Disease (CKD) Not on Dialysis

NCT02238067 | Completed Results

• 1 other identifier: ML25473
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 7

Brief Summary

This study is a prospective, non-interventional, cross-sectional multicenter survey. The aim is to better understand the current therapy pattern for anemia in CKD treated with erythropoiesis-stimulating agents (ESAs) and not on-dialysis participant population in Israel. Participating physicians will be requested to interview eligible participants with CKD not on dialysis and to complete for them a satisfaction survey for anemia treatment. The survey will be completed twice, once at study start and once at six months' follow-up.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants by ESA Types at Baseline

  Assessment was performed by physician via a satisfaction survey on anemia treatment. ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type was reported.

  Baseline

• Percentage of Participants by ESA Types at Month 6

  Assessment was performed by physician via a satisfaction survey on anemia treatment. ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type was reported.

  Month 6

• Percentage of Participants by Frequency of ESA Use at Baseline

  Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). Percentage of participants by each frequency of ESA use was reported.

  Baseline

• Percentage of Participants by Frequency of ESA Use at Month 6

  Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). Percentage of participants by each frequency of ESA use was reported.

  Month 6

• Percentage of Participants by Frequency and Types of ESA Used at Baseline

  Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type and each frequency of ESA use was reported.

  Baseline

• Percentage of Participants by Frequency and Types of ESA Used at Month 6

  Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type and each frequency of ESA use was reported.

  Month 6

Secondary Outcomes (14)

• Percentage of Participants by Different CKD Stages

  Baseline, Month 6

• Percentage of Participants by Different Injection Administration Modes

  Baseline, Month 6

• Percentage of Participants With Interest in Learning to Inject Independently

  Baseline, Month 6

• Percentage of Participants by Need for Improvement in Treatment Frequency

  Baseline, Month 6

• Percentage of Participants by Need for Improvement in Treatment Frequency by ESA Type

  Baseline, Month 6

Study Arms (1)

Chronic Renal Anemia Participants

Participants with CKD who are not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, will be interviewed by physician who will complete the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.

Drug: ESA; Other: Satisfaction Survey Questionnaire

Interventions

ESA DRUG

Participants will continue to receive their ESA treatment, as per physician's discretion. The study protocol does not specify any particular ESA drug.

Chronic Renal Anemia Participants

Satisfaction Survey Questionnaire OTHER

Each participant will be interviewed to complete treatment satisfaction questionnaire survey at baseline and at 6-month follow-up visit.

Chronic Renal Anemia Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with CKD not on-dialysis treated with ESAs

You may qualify if:

• Adult participants with CKD Stage 3-5
• Treated with ESAs
• Participant is speaking the same language as the investigator interviewer

You may not qualify if:

• Past or current treatment with dialysis

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Clalit- New Savyon Clinic

Ganey Tikva, Israel

Location

Clalit - Diabetic HaMoshava South Clinic

Jerusalem, Israel

Location

Clalit Carmiel

Karmiel, Israel

Location

Clalit - Professional Clinic, Zvulun

Kiryat Bialik, Israel

Location

Clalit Ben-Gurion

Naẕerat ‘Illit, Israel

Location

Kaplan Medical Center; Nephrology and Hypertension Services

Rehovot, 76100, Israel

Location

Clalit- Migdal HaMea Clinic, Tel Aviv

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

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

The study was completed as defined in the protocol. Only 196 participants (out of planned 400) were enrolled due to slow recruitment during the study period.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 24, 2017
• Results First Posted: November 7, 2016

Record last verified: 2017-02

Locations

IL (7)