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Virus Therapy

A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection

Phase 2
Waitlist Available
Research Sponsored by Nobelpharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks

Summary

This trial is testing NPC-21, a new drug, to see if it can prevent CMV infections in patients who have just received their first kidney transplant from donors with CMV. These patients are at high risk because they do not have immunity against the virus. NPC-21 aims to protect them by stopping the virus from infecting their bodies.

Eligible Conditions
  • Cytomegalovirus (CMV)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Incidence of CMV Disease
Incidence of CMV Disease or CMV Viremia
Incidence of CMV Viremia
+3 more

Side effects data

From 2023 Phase 2 trial • 87 Patients • NCT04225923
50%
Cytomegalovirus viraemia
29%
Diarrhoea
18%
Oedema peripheral
16%
Urinary tract infection
16%
Tremor
13%
Hypomagnesaemia
13%
Leukopenia
13%
Vomiting
11%
Neutropenia
11%
Pyrexia
11%
Weight decreased
11%
Hyperkalaemia
8%
Stomatitis
8%
Dyspepsia
8%
Hypophosphataemia
8%
Dizziness
8%
Nausea
8%
Fatigue
5%
Blood creatinine increased
5%
Chills
5%
Constipation
5%
Decreased appetite
5%
Anaemia
5%
White blood cell count decreased
5%
Polyomavirus viraemia
5%
Hypotension
5%
Incision site pain
5%
Hypertension
5%
Rash
5%
Transplant rejection
5%
Donor specific antibody present
5%
Arthralgia
5%
Dysuria
5%
Deep vein thrombosis
5%
Headache
5%
Hyperglycaemia
5%
Myalgia
5%
Urosepsis
3%
Pruritus
3%
Pain in extremity
3%
Insomnia
3%
Orthostatic hypotension
3%
Diabetic ketoacidosis
3%
Oesophageal ulcer
3%
Cytomegalovirus syndrome
3%
Lipase increased
3%
Nocturia
3%
Blood loss anaemia
3%
Nasopharyngitis
3%
Syncope
3%
Cellulitis
3%
Acute kidney injury
3%
Asthenia
3%
Klebsiella infection
3%
Staphylococcal infection
3%
Retroperitoneal haematoma
3%
Osteomyelitis
3%
Abdominal pain
3%
Cytomegalovirus infection
3%
Dyspnoea
3%
Cytomegalovirus gastroenteritis
3%
Tachycardia
3%
Septic shock
3%
Vitamin D deficiency
3%
Haematuria
3%
Back pain
3%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPC-21 Low Dose
NPC-21 High Dose
NPC-21 Placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: NPC-21 Low doseExperimental Treatment1 Intervention
NPC-21 (6mg/kg) will be administered
Group II: NPC-21 High doseExperimental Treatment1 Intervention
NPC-21 (12mg/kg) will be administered
Group III: NPC-21 PlaceboPlacebo Group1 Intervention
Placebo (normal saline) will be administered
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NPC-21 High dose
2020
Completed Phase 2
~90
NPC-21 Low dose
2020
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

NobelpharmaLead Sponsor
35 Previous Clinical Trials
2,110 Total Patients Enrolled
~16 spots leftby Dec 2025
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