An Observational Study to Describe Calcimimetic Use in HD Patients
Research type
Research Study
Full title
A Multi-country Prospective Observational Study to Describe Calcimimetic Use in Haemodialysis Patients
IRAS ID
273403
Contact name
Matthew Hall
Contact email
Sponsor organisation
Amgen Ltd
Clinicaltrials.gov Identifier
EUPAS18923, The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) Number:
Duration of Study in the UK
0 years, 10 months, 10 days
Research summary
Research Summary
This multi-country observational study will describe the current use of two drugs (cinacalcet and etelcalcetide) that mimic the action of calcium on tissue - collectively known as calcimimetics - in a population of adult patients with chronic kidney disease (CKD), receiving haemodialysis (HD) therapy. There is a lack of data describing etelcalcetide use and effectiveness in the clinic. This study will provide context by observing real world use of etelcalcetide and cinacalcet. The main aim of this study is to describe the number of HD patients that stop calcimimetics at 3-monthly intervals, up to 18 months following the treatment starting. How these patients are treated will also be described. A total of 24 months of data will be collected for each patient.
Summary of Results
A Multi-country Prospective Observational Study to Describe Calcimimetic Use in Haemodialysis Patients Protocol Number:
20150297
Date of This Summary:
19 August 2022
What does this summary cover?
This summary describes the main results from one observational/non-interventional study. This study involved the collection of data from medical records and was not designed to evaluate 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 the manufacturer of etelcalcetide, which is marketed as Parsabiv®, and cinacalcet, which is marketed as Mimpara®, the medicines reviewed 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 Where and when was the study done?
• This study took place in Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Portugal, Russian Federation, Slovenia, Spain, and the United Kingdom.
• The study began in June 2018 and ended in November 2021.
• The study was completed as planned.
Why was the study done?
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 generally 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.
Which medicines were studied?
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) How was the study done?
Previous research has been done on the safety and effectiveness of cinacalcet and etelcalcetide. In this study, researchers wanted to learn more about how calcimimetics are used in routine medical practice. The researchers reviewed participants’ medical records at 3-month intervals to find out how many participants stopped taking calcimimetics. A total of 24 months of data was reviewed for each participant, starting from 6 months before they started calcimimetics and ending 18 months after they started taking calcimimetics. The researchers looked at 3 different groups of participants: those who were starting cinacalcet and had never tried a calcimimetic before; those who were starting etelcalcetide and had never tried a calcimimetic before; and those who were switching from cinacalcet to etelcalcetide.
4. Who Was Included in This Study?
Study participants were adult patients starting calcimimetic treatment (either oral cinacalcet or IV etelcalcetide). Out of 1446 participants assessed in the study, 845 (58%) were men and 601 (42%) were women. Participants were between 18 and 94 years of age, with an average age of 61 years.
This study took place at 111 study centers worldwide. The number of participants in each country are listed below.
Countries Participants
Austria
26
Belgium
50
Czech Republic
90
Denmark
11
France
120
Germany
55
Greece
347
Hungary
92
Israel
30
Italy
184
Netherlands
20
Portugal
71
Russian Federation
119
Slovenia
15
Spain
186
United Kingdom
30
5. What Were the Side Effects?
All medicines can cause side effects, or unwanted medical problems that may happen when you take a medicine. Doctors believed some of the problems could have been caused by the study medicine(s).
The table below shows how many participants had side effects during this study. Side Effects During the Study New to Cinacalcet (284 Participants) New to Etelcalcetide (736 Participants) Switching from Cinacalcet to Etelcalcetide (455 Participants) Total Etelcalcetide (1191 Participants) How many participants had side effects?
22 participants (8%)
85 participants (12%)
66 participants (15%)
151 participants (13%) How many participants had serious side effects? 4 participants (1%) 5 participants (1%) 4 participants (1%) 9 participants (1%) How many participants stopped taking the study medicine because of side effects?
4 participants (1%)
10 participants (1%)
13 participants (3%)
23 participants (2%) How many participants died from side effects? 0 participants (0%) 0 participants (0%) 0 participants (0%) 0 participants (0%) If a participant had to stay in the hospital or died because of a side effect, the doctor reported that the side effect was serious. No participant died due to a side effect.
6. What Were the Overall Results of the Study?
Overall, 31% of participants in the cinacalcet group, 20% of participants in the etelcalcetide group, and 18% of participants in the switching group stopped calcimimetic treatment during the study.
The average time until participants stopped calcimimetic treatment was 8.4 months for the cinacalcet group, 9.1 months for the etelcalcetide group, and 8.8 months for the switching group.
The table below shows the number and percent of participants in who had stopped calcimimetic treatment by 3-month interval.
Number and Percent of Participants Who Had Stopped Calcimimetic Treatment By 3-Month Interval Interval New to Cinacalcet (274 Participants) New to Etelcalcetide (722 Participants) Switching from Cinacalcet to Etelcalcetide (450 Participants) Total Etelcalcetide (1172 Participants) Month 3
17 (6%)
23 (3%)
12 (3%)
35 (3%) Month 6 30 (11%) 48 (7%) 31 (7%) 79 (7%) Month 9
47 (17%)
75 (10%)
43 (10%)
118 (10%)
Month 12 62 (23%) 99 (14%) 56 (13%) 155 (13%) Month 15
76 (28%)
118 (16%)
68 (15%)
186 (16%) Month 18 86 (31%) 141 (20%) 80 (18%) 221 (19%) 7. How Has This Study Helped Participants and Researchers?
This study may help future patients and families by providing information to help doctors understand more about the medicines in this study. This study helped researchers understand how calcimimetics are used in routine practice.
8. What else is important to know about these results?
These results are only for this observational study, which looked at a sample of 1446 participants with SHPT in the 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.
9. Are There Plans for Further Studies?
More information on other studies may be listed on public websites, such as those below, where you can search for the study medicine names etelcalcetide (Parsabiv®) and cinacalcet (Mimpara®), or the disease state secondary hyperparathyroidism.
• https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C1c94fdf357da42f56d0108da9d75dff6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637995426852573412%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=oy%2B0Hrt17QIaAwn5QYlgWY%2FBFE8zvfybpPObUrTNbLo%3D&reserved=0
• https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C1c94fdf357da42f56d0108da9d75dff6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637995426852573412%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=HUF0rDNRffF3OcEsO%2FuQQO4kgFpyv0WoBK3bH%2F9QnEo%3D&reserved=0
• https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.encepp.eu%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C1c94fdf357da42f56d0108da9d75dff6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637995426852573412%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=gYwR%2Fm4NORCueDJ2rY78QB09pWJPaPqic15FuFAwVnE%3D&reserved=0 Use the study identifier EUPAS18923 If 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 - Berkshire B Research Ethics Committee
REC reference
19/SC/0611
Date of REC Opinion
5 Feb 2020
REC opinion
Further Information Favourable Opinion