The Evaluation of the Efficacy of Calcitriol Compared to Calcitriol plus Cinacalcet in the Treatment of Severe Secondary Hyperparathyroidism in Hemodialysis Patients Referred to Dialysis Centers in Gorgan
Determination of the effect of Calcitriol in comparison with Calcitriol plus Cinacalcet in treatment of severe secondary hyperparathyroidism in dialysis patients
Design
A randomized, phase II, single-blinded clinical trial with a parallel group includes 70 patients in which to randomize the samples with a randomized block design, four blocks is used.
Settings and conduct
Dialysis patients with severe secondary hyperparathyroidism who are eligibile to participate in the study referred to dialysis centers in Gorgan are randomly divided into the two intervention groups: A) Rocaltrol and (B Cinacalcet + Rocaltrol. This study is single-blinded that the person who that the person who compares the groups and analyses the results of the study are unaware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: over 18 years old; dialysis for at least 3 months; iPTH levels above 800 pg/dL (severe secondary hyperparathyroidism); Do not take medications that have interactions with studied medications; No known hypersensitivity reaction to the drugs; No known liver disease; Calcium levels > 8.4 mg/dL. Exclusion criteria: any type of cancer in different parts of the body; Side effects of the medications; Diseases causing hypercalcemia; History of parathyroidctomy; Presence of parathyroid adenoma; Pregnant mothers or lactating women or females of childbearing age without use of contraception.
Intervention groups
Intervention group A: Receiving Calcitriol 1 mg orally every other night and intervention group B: Receiving Calcitriol 1 mg orally every other night plus Cinacalcet 30 mg orally daily.
Main outcome variables
Decreased parathyroid hormone levels and decreased serum phosphorus and calcium levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200218046533N1
Registration date:2020-05-31, 1399/03/11
Registration timing:prospective
Last update:2020-05-31, 1399/03/11
Update count:0
Registration date
2020-05-31, 1399/03/11
Registrant information
Name
Saeid Amirkhanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3225 1502
Email address
amirkhanlo-md@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-01, 1399/03/12
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of the Efficacy of Calcitriol Compared to Calcitriol plus Cinacalcet in the Treatment of Severe Secondary Hyperparathyroidism in Hemodialysis Patients Referred to Dialysis Centers in Gorgan
Public title
Efficacy of Cinacalcet in the Treatment of Secondary Hyperparathyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 years and more;
Dialysis for at least 3 months;
iPTH levels above 800 pg/dL (severe secondary hyperparathyroidism);
Do not take medications that have drug interactions such as flecainide, thioridazine, tricyclic antidepressants due to the effect of Cinacalcet on the P-450 cytochrome;
No hypersensitivity reaction to the drugs used in the study;
No liver disease;
Calcium levels > 8.4 mg/dL.
Exclusion criteria:
Any evidence of cancer in different parts of the body;
Side effects of the medications used during the study period;
Diseases causing hypercalcemia;
History of parathyroidctomy;
Presence of parathyroid adenoma (to be confirmed by parathyroid scan);
Pregnant mothers or lactating women or females of childbearing age who do not currently use contraception.
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the samples with a randomized block design, four blocks is used, so that one of the blocks is first selected randomly (for example, with a dice) and according to its order, the samples are allocated to two groups: A) for receiving Rocaltrol and (B receiving Cinacalcet + Rocaltrol.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single-blind so the person who compares the results and analyses the data of the study will be unaware of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Gorgan-Sari headway, beginning of Shast Kola road, Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.GOUMS.REC.1398.042
Health conditions studied
1
Description of health condition studied
Secondary hyperparathyroidism
ICD-10 code
N25.81
ICD-10 code description
Secondary hyperparathyroidism of renal origin
Primary outcomes
1
Description
Decreased parathyroid hormone levels
Timepoint
Before study and 3 and 6 months after treatment
Method of measurement
Blood test
Secondary outcomes
1
Description
Decreased serum phosphorus and calcium levels
Timepoint
Before study and 3 and 6 months after treatment
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group A: Receiving Calcitriol 1 mg orally every other night
Category
Treatment - Drugs
2
Description
Intervention group B: Receiving Calcitriol 1 mg orally every other night plus Cinacalcet 30 mg orally daily.