| CTRI Number |
CTRI/2020/07/026718 [Registered on: 21/07/2020] Trial Registered Prospectively |
| Last Modified On: |
20/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Darbepoetin Alfa |
|
Scientific Title of Study
|
A Phase I, single blind, randomized, controlled clinical study of the pharmacokinetics, pharmacodynamics, Tolerability and Safety of Multiple Intravenous Injections of Darbepoetin alfa, (manufactured by Hetero Biopharma Ltd., India.) and ‘ARANESP®’ (Darbepoetin alfa Injection, manufactured by Amgen Inc., USA.) in healthy adult male volunteers.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RBP/I/DPA-2/2019 Version No.: 1.0, Dated: 23/04/2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Chaudhari |
| Designation |
Principal Investigator |
| Affiliation |
MALSONS Multispeciality Hospital |
| Address |
Department of
Medicine, Ground
Floor, Plot no. 135
Sector 06,
Koparkhairane,
Navi Mumbai, India
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
|
| Fax |
|
| Email |
dranandchaudhari100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suresh Chandra |
| Designation |
Head Regulatory |
| Affiliation |
Camus Pharma |
| Address |
29-B, Suraj Nagar East, Camus House, Civil Lines, Jaipur-Rajasthan-India-302006
Jaipur
RAJASTHAN
302006
India |
| Phone |
|
| Fax |
|
| Email |
suresh@camuspharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Suresh Chandra |
| Designation |
Head Regulatory |
| Affiliation |
Camus Pharma |
| Address |
29-B, Suraj Nagar East, Civil Lines, Jaipur-Rajasthan-India-302006
Jaipur
RAJASTHAN
302006
India |
| Phone |
|
| Fax |
|
| Email |
suresh@camuspharma.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PSK Pharma LLC |
| Address |
141983,Moscow Region, Dubna,4 Programmistov street, building 2,
suite 215 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Camus Pharma Pvt Ltd |
Camus House, 29-B, Suraj Nagar East, Civil
Lines, Jaipur-Rajasthan-India-302006 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A Chaudhari |
MALSONS Multispeciality Hospital and ICU |
Department of
Medicine, Ground
Floor, Plot no. 135
Sector 06,
Koparkhairane,
Mumbai (Suburban)
MAHARASHTRA |
8291745386
dranandchaudhari100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashirwad Institutional Ethics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aranesp® (darbepoetin
alfa) injection |
for intravenous use, 1 μg/kg. Manufactured
by Amgen Inc., USA. |
| Intervention |
Darbepoetin
(darbepoetin alfa)
injection |
for intravenous use, 1 μg/kg. Manufactured
by Hetero Biopharma Ltd., India. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. BMI: 18.5 to 30.0 kg/ (height in meter)2; BMI value should be rounded
off to one significant digit after decimal point (e.g., 30.04 rounds down to
30.0, while 18.45 rounds up to 18.5).
2. Adequate liver and kidney function [AST, ALT, alkaline phosphatase
and bilirubin ≤1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if
bilirubin is fractionated and direct bilirubin <35%].
3.Adequate Iron [Adequate iron stores (transferrin saturation ≥20% and
serum ferritin ≥200 ng/mL or within laboratory reference range), total iron
binding capacity within laboratory reference.
4. Adequate levels of hemoglobin at baseline (120 g/L to 150 g/L)
5. Adequate levels of hematocrit at baseline (41% to 49%) |
|
| ExclusionCriteria |
| Details |
1. History of allergic responses or hypersensitivity to Darbepoetin alfa or
other related drugs, or any of its formulation ingredients.
2. Have significant diseases or clinically significant abnormal findings during
screening, [medical history, physical examination, laboratory evaluations,
ECG and chest X-ray recording].
3. Subjects with psychiatric disorders or other conditions that can affect
the ability of the subject to follow the study protocol
4. Subjects having history of Epileptic seizures within six months prior to
the first administration of the investigational product
5. Acute infections within 4 weeks before the start of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Cmax after 1st and 4th dosing of Darbepoetin alfa
2. AUC0-72 after 1st and 4th dosing of Darbepoetin alfa
3. Darbepoetin alfa AUCi
4. Darbepoetin alfa Tmax
5. Darbepoetin alfa Cmax
6. Darbepoetin alfa t1/2
7. Darbepoetin alfa Kel |
1. after 1st and 4th dosing of Darbepoetin alfa
2. after 1st and 4th dosing of Darbepoetin alfa
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. AUEC1-29
|
After 1st Dose
|
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
27/07/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165- amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons. Darbepoetin alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. Darbepoetin alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy. The study will be conducted in accordance with the principles set forth in the Helsinki Declaration (1964, amended in October 2013, Brazil) and as per ICH – GCP guidelines. The subjects will be counseled and upon receiving voluntarily written informed consent, the subjects will be screened. This will be a Phase 1, single Blind, Randomized, Parallel-group, multiple-dose, Comparative Pharmacokinetic, Safety, and Tolerability Study. The study will begin with screening evaluation of healthy human volunteers at screening. Subjects satisfying all the inclusion criteria at Enrollment visit will be randomized. |