Amgen CAP Pilot
Research type
Research Study
Full title
Calcimimetics Adherence and Preference Study in the Management of Secondary Hyperparathyroidism in DOPPS (Dialysis Outcomes and Practice Patterns Study) in Europe
IRAS ID
266135
Contact name
Matthew Hall
Contact email
Sponsor organisation
Amgen
Clinicaltrials.gov Identifier
EUPAS27845 , EU Post Authorization Study
Duration of Study in the UK
0 years, 4 months, 13 days
Research summary
Summary of research
Calcimimetics are medicines that mimic the action of calcium on body tissues and they are used in the clinical management of secondary hyperthyroidism (SHPT) patients that need hemodialysis (HD). An oral and an intravenous calcimimetic are currently available to patients and this study aims to investigate the experiences of patients receiving oral treatment versus intravenous treatment; along with the prescribing preference of the healthcare professional.
The study will use a survey questionnaire to collect information on patient self-reported treatment adherence, as well as how their symptoms and treatment intrusiveness affects this. A survey will also be conducted among healthcare professionals providing these treatments to investigate their preferences and experiences.Summary of Results
This summary shows the main results from one observational/non-interventional study. This study involved the collection of data from medical records and surveys and was not designed to evaluate safety and efficacy. The results of this summary are only for this study. Other studies may find different results. Researchers and health authorities look at the results of many studies to decide which medicines work best and are safest for patients.Amgen has committed to make research results available to the public. This summary has been provided as part of that commitment and should not be used for any other purpose. It should not be considered to make a claim for any product or to guide treatment decisions.
Some information in this summary may be different from the approved labelling for etelcalcetide and cinacalcet. Your healthcare professional should refer to the full prescribing information for proper use of etelcalcetide and cinacalcet.
2. Who Sponsored This Study?
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 USA Phone: +44 1223 436441 Amgen Inc. is the sponsor of the study and made etelcalcetide and cinacalcet, the medicines tested in the study.Amgen would like to thank everyone who participated in this study and feels it is important to share the results of this study.
3. General Information About the Clinical Study
• This study took place in Belgium, France, Germany, Italy, Spain, Sweden, and the United Kingdom.
• The study began in October 2019 and ended in September 2021.
• The study was completed as planned.Chronic kidney disease (also called “CKD”) is a serious health problem where the kidneys are diseased or damaged. The kidneys are not able to control the amount of water flowing through the body or filter waste out of the blood like they should. CKD will continue to get worse over time. Once the kidneys fail, treatment is needed, including dialysis. Dialysis uses a machine to filter the blood like healthy kidneys would.
Patients with CKD often have a problem called secondary hyperparathyroidism (also called “SHPT”). SHPT is caused by too much of a certain hormone called parathyroid hormone. Parathyroid hormone controls how much calcium is in the blood. Calcium is an important mineral our body needs for a healthy heart, bones, nervous system, and hormone control. Parathyroid hormone causes minerals, like calcium, to leave the bones and enter the blood.
Calcimimetics are medicines which are used to treat SHPT, and currently 2 are available. The 2 calcimimetics that are available to treat SHPT were examined in this study:
• Cinacalcet (Mimpara®): Oral (tablet taken by mouth)
• Etelcalcetide (Parsabiv®): IV (intravenous, given through the dialysis tubing)Previous research has been done on the safety and effectiveness of cinacalcet and etelcalcetide. In this study, researchers surveyed participants with SHPT to find out how well they were able to take calcimimetics as prescribed. This is known as “adherence.” Researchers also conducted a survey of nephrologists (physicians who specialize in treating kidney problems) and dialysis nurses. They wanted to find out if these healthcare professionals had a preference for prescribing oral cinacalcet or IV etelcalcetide to patients with SHPT.
Survey questionnaires for patients were adapted from the Medication Adherence Report Scale (MARS-5), and included questions to understand how well they were able to consistently follow the calcimimetic treatment schedule.
This study was done in 2 parts. The first part of the study was called the pilot study, which was done to test the survey questionnaires with a smaller group of participants. The main part of the study included 2 visits: at enrollment (visit 1) and within 3 months afterwards (visit 2).
4. Who Was Included in This Study?
Patients were eligible to join the study if they were adults receiving maintenance hemodialysis and calcimimetic treatment (either oral cinacalcet or IV etelcalcetide) at the time of recruitment. Out of 394 patient participants in the main part of the study, 233 (59%) were men and 153 (41%) were women. The average age was about 65 years.
Nephrologists and dialysis nurses were eligible to join the study if they had experience with using calcimimetics to treat patients with SHPT undergoing hemodialysis. The nephrologists taking part in this study had on average 15 years of experience, and the nurses had 14 years.
The table below shows the number of participants in the study.
Number of Patient Participants in the Study
Total Participants Cinacalcet Etalcalcetide
Pilot Study
Participants 60 33 27
Main Study, Visit 1
Participants 414 204 210
Main Study, Visit 2
Participants 394 190 204Number of Healthcare Professional Participants in the Study
Total Participants Nephrologists Dialysis Nurses
Pilot Study
Participants 60 33 27
Main Study
Participants 34 16 18This study took place at 77 study centers across Belgium, France, Germany, Italy, Spain, Sweden, and the United Kingdom. The number of participants in each country are listed below.
Countries Patients Nephrologists Nurses
France 58 13 15
Belgium 71 27 31
Italy 107 27 26
UK 71 20 19
Germany 36 8 9
Sweden 5 1 1
Spain 75 15 13
5. What Were the Overall Results of the Study?How well did participants adhere to oral cinacalcet treatment, when compared with IV etelcalcetide?
Participants provided comparable responses after both their visits of the main study.
Participants who received etelcalcetide received it under healthcare supervision because it is given through an IV, so adherence to the medicine was assumed to be 100%. However, participants who received cinacalcet (oral) took it by themselves. More than 3 in 4 participants (78%) reported that they took all the cinacalcet they were prescribed in the last month prior to enrollment in the study. This is considered to be a high adherence.
Did the physicians and nurses have a treatment preference?
The nephrologists and nurses who participated in this study preferred prescribing etelcalcetide (IV) to cinacalcet (oral). The main reasons were encouraging patient adherence, minimizing patient burden, minimizing side effects, improving quality of life and general efficacy, and reducing the need for surgery to remove the parathyroid gland (parathyroidectomy). These reasons are shown in the table below.
Treatment Preference of the Physicians and Nurses Reason Preference for Etelcalcetide Preference for Cinacalcet Preferred to encourage patient adherence No Preference
Nephrologists 89% 4% 7%
Nurses 78% 9%
12%
Preferred to minimize patient burden
Nephrologists 87% 5% 9%
Nurses 86% 5%
8%
Preferred to minimize side effects
Nephrologists 78% 3% 20%
Nurses 66% 9%
25%
Preferred to improve quality of life
Nephrologists 72% 4% 24%
Nurses 75% 5%
19%
Preferred to reduce the need for surgery to remove parathyroid gland
Nephrologists 47% 5% 48%
Nurses 55% 8%
36%
Preferred due to general efficacy
Nephrologists 60% 16% 24%
Nurses 74% 5%
20%6. How Has This Study Helped Participants and Researchers?
This study may help future patients and families by helping doctors understand more about the medicines in this study. This study helped researchers understand how well patient participants with SHPT typically follow their calcimimetic treatment while on maintenance hemodialysis. It also added knowledge about the real-life treatment preferences of nephrologists and dialysis nurses.
The main limitation of this study is that participants might not precisely remember the details of whether they took their medicine as prescribed. Another limitation is called bias, which is when participants may provide responses (intentionally or unintentionally) that they may view as being expected. These limitations were minimized by asking questions in a timely manner and by reassuring all participants that all data will remain anonymous and will not affect their treatment or care in any way. Questions were worded simply to avoid any potential bias.
7. What else is important to know about these results?
These results are only for this clinical study, which looked at a sample of 60 participants with SHPT in the pilot study, 414 participants during the first visit of the main study, and 394 participants during the second visit of the main study. Not all participants in the study had the same responses. Other studies may find different results. These results do not explain how a medicine may work in a single person. Many studies in participants with a particular disease are needed to show the benefits and risks of a medicine.
8. Are There Plans for Further Studies?
More information on other studies may be listed on public websites, such as those below. Search for study medicine names etelcalcetide (Parsabiv®) and cinacalcet (Mimpara®) on the websites below.
• https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C76b3938fb5ef4abcd18208da8426860f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637967598248048798%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=2dztb6UPYiaCZZP0E0PZf%2FTyWFvtW7lJIAPGol1HmXI%3D&reserved=0
• https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C76b3938fb5ef4abcd18208da8426860f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637967598248048798%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=od1HwAD4T4WnZNhdgInwXQEOP0b4ahor3YJUuD42YHE%3D&reserved=0If you participated in the study and have questions about the study results, the doctor or staff at your study center may be able to answer them.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0660
Date of REC Opinion
10 Jan 2020
REC opinion
Favourable Opinion