Primary objective(s): To assess the effect of LysaKare® administration on serum potassium concentration in GEP-NET patients eligible for Lutathera® treatmentSecondary objective(s): To confirm the safety profile of LysaKare® infusion in GEP-NET…
ID
Source
Brief title
Condition
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in serum potassium levels at specified time points after LysaKare® IV
administration compared to baseline.
Secondary outcome
* Incidence of LysaKare® related adverse events
* Changes in vital signs and ECG parameters
* Change in laboratory parameters
Background summary
This is a category 3 Post-Authorization Safety Study (PASS) following the
European Medicines Agency (EMA) marketing authorization of LysaKare® 25g / 25g
solution for infusion. LysaKare® is indicated for reduction of renal radiation
exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium
(177Lu) oxodotreotide in adults. The marketing authorization was granted based
on literature data from similar solutions, which have been used for >10 years
in Europe (well established use application).
The purpose of the study is to evaluate the effect of LysaKare® administration
on serum potassium levels. A systematic assessment of serum potassium levels
will be performed during infusion and up to 24 hours post start of infusion
compared to baseline.
Study objective
Primary objective(s): To assess the effect of LysaKare® administration on serum
potassium concentration in GEP-NET patients eligible for Lutathera® treatment
Secondary objective(s): To confirm the safety profile of LysaKare® infusion in
GEP-NET patients eligible for Lutathera® treatment without co-administration of
Lutathera®
Study design
This is a multicenter, open-label post-authorization safety study (PASS).
Overall, 40 patients with GEP-NET will be enrolled to receive one infusion with
LysaKare® to systematically assess the effect of LysaKare® administration on
potassium blood level concentration up to 24 h compared to baseline.
The study schedule for each patient consists of a screening period followed by
an infusion day with an optional overnight in-clinic stay, and a follow up
call.
Intervention
Subjects will receive 1 x 4 hour infusion with Lysakare.
Study burden and risks
The study schedule for each patient consists of a screening period followed by
an infusion day with an optional overnight in-clinic stay, and a follow up call.
In total, the patients will receive 3 x physical exam, 8 x measurements of
vital signs, 5 x ECG, 8 x blood test, and a 1 x 4 hour infusion with
Lysakare®. On the infusion day, the patients are instructed to drink at least 1
glass of water every hour. If patients are female of childbearing potential,
they will have 2 x pregnancy tests.
Risk-benefit analysis:
Amino acid solutions with similar composition to LysaKare® have been widely
used for renal protection during PRRT treatment.
The evaluation of potential risks of LysaKare® for this study is based on the
literature data presented in the well-established use application. The
LysaKare® IB (Guidance to the Investigator) summarizes potential risks and key
risk management activities to consider when administering LysaKare®. The main
adverse reactions reported after the amino acid solution administration include
nausea, vomiting and hyperkalemia.
* Nausea and vomiting
The main adverse reactions are nausea (approximately 25%) and vomiting
(approximately 10%). Pre-treatment with an anti-emetic 30 minutes prior to
start of LysaKare® infusion is recommended to reduce the incidence of nausea
and vomiting.
* Hyperkalemia
An increase of serum potassium levels may occur. Serum potassium level
increases are generally mild and transient. Vital signs should be monitored
during the infusion regardless of baseline serum potassium levels. Patients
should be instructed to drink substantial quantities of water (at least 1 glass
every hour) on the day of infusion to remain hydrated and facilitate excretion
of excess serum potassium. In case hyperkalemia symptoms develop during
LysaKare® infusion, appropriate corrective measures must be taken.
Safety effects of LysaKare® will be carefully assessed in this study, and
patients will be closely monitored.
As LysaKare® is administered in medical practice with Lutathera® as a kidney
radiation protection agent and it does not have a therapeutic effect on GEP-NET
itself, there is no direct benefit to the patients participating in the study.
However, this study will be essential in better understanding the effect of
LysaKare® on serum potassium levels in the GEP-NET patient population for its
safe use with Lutathera®.
Rue de la tour de l'ile 4
Geneva 2104
CH
Rue de la tour de l'ile 4
Geneva 2104
CH
Listed location countries
Age
Inclusion criteria
1. Male or female patients with somatostatin receptor positive
gastroenteropancreatic neuroendocrine tumours (GEP-NETs), who are eligible for
the treatment with Lutathera® as per Lutathera® label indication.
2. Age *18 years.
3. Patients who have provided a signed informed consent form to participate in
the study, obtained prior to the start of any protocol related procedures.
Exclusion criteria
1. Pre-existing hyperkalemia (>6.0 mmol/L at screening) if not adequately
corrected before starting the LysaKare® infusion.
2. Instances when Lutathera® is not recommended per the Lutathera® SmPC:
a. Uncontrolled congestive heart failure (NYHA III, IV);
b. Kidney failure with creatinine clearance < 50 mL/min calculated by the
Cockroft Gault method;
c. Impaired haematological function with either Hb < 4.9 mmol/L (8 g/dL),
platelets < 75 G/L (75x103/mm3), or leucocytes < 2 G/L (2,000/mm3) (except
lymphopenia);
d. Liver impairment with either total bilirubinemia > 3 times the upper limit
of normal or albuminemia < 30 g/L and prothrombin ratio decreased < 70%.
3. Pregnancy or lactation, positive pregnancy test at screening or pre-dose
based on the contraindication for Lutathera®.
4. Hypersensitivity to the IMP active substances.
5. Any significant medical or social condition which may interfere with the
subject*s ability to comply with the study visit schedule or the study
assessments.
6. Patients who have received any investigational agent within the last 30 days.
7. Patients that have received a dose of Lutathera® prior to the screening
visit or are scheduled for Peptide Receptor Repeat (PRRT) treatment within 7
days of the study infusion of LysaKare®.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-004073-76-NL |
| CCMO | NL73929.078.20 |