A Phase 2 interventional study of Mirogabalin (Intermittent) and Mirogabalin (Daily) in Uremic Pruritus, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Alexandria University · Phase 2, Interventional, and Treatment
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Among 17 studies in Pruritus with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Pruritus · Egypt.
Among the 17 studies in Pruritus with a site in Egypt, this one is the 4th largest by planned enrollment of the 16 interventional ones that give a count, is the only one that started in 2026, is one of 5 in phase 2, and was the 17th registered.
491 studies on the registry are indexed under Pruritus; 94 are open to participants now.
Browse Pruritus studies →2 of the 17 studies in Pruritus with a site in Egypt are open now. Recruiting first, the newest first:
Ain Shams University · Sites in Egypt
Ages 18–70
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 54 Pruritus studies recruiting now, 22 (41%) set no upper age limit and 24 (44%) stop at 75 or younger; 15 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is above the median of 60 across 423 interventional studies indexed under Pruritus.
Median enrollment 75 across the 16 interventional studies, 60 across the 1 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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None of the 17 has an industry lead sponsor. The 10 most frequent:
Alexandria University is the lead sponsor of 607 studies on the registry; 142 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Alexandria University has 4 studies filed under Pruritus — fewer than ten, so there is no comparison to draw.
1 of the studies in Pruritus with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07936292Alexandria UniversityEfficacy and Safety of Mirogabalin in Uremic Pruritus | 2027-03 |
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Among the 17 studies in Pruritus with a site in Egypt, from their registry updates:
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This study aims to assess the efficacy and safety of mirogabalin in alleviating moderate-to-severe uremic pruritus in patients undergoing maintenance hemodialysis, and to establish the optimal dosing frequency by comparing continuous daily administration against intermittent post-dialysis administration.
Uremic pruritus is a prevalent and distressing condition affecting over 60% of patients undergoing hemodialysis, with 20% to 40% experiencing moderate-to-severe symptoms. This condition is strongly associated with poor sleep architecture, depression, diminished quality of life, and an increased risk of mortality. The exact pathogenesis is multifactorial, involving metabolic disturbances, dysregulated immune responses, imbalances in the endogenous opioid system, and peripheral neuropathy.
While current off-label therapies for uremic pruritus include gabapentinoids targeting neuropathic mechanisms, their clinical utility in end-stage renal disease (ESRD) is severely limited by dose-dependent central nervous system (CNS) toxicity, particularly somnolence and dizziness. Mirogabalin is a novel, preferentially selective α2δ - 1 ligand hypothesized to provide robust anti-pruritic efficacy with a significantly lower incidence of neurotoxicity. Because mirogabalin is primarily eliminated by the kidneys, this trial will evaluate the efficacy, safety, and optimal dosing frequency (daily versus post-dialysis intermittent dosing) to prevent drug accumulation in the hemodialysis population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive mirogabalin 5 mg three times per week, administered immediately after each hemodialysis session for the 12-week duration.
Drug: Mirogabalin (Intermittent)
Patients will receive mirogabalin 5 mg once daily for the 12-week duration.
Drug: Mirogabalin (Daily)
Patients will receive a matched placebo for the 12-week duration.
Drug: Placebo
Patients will receive mirogabalin 5 mg three times per week, administered immediately after each hemodialysis session for the 12-week duration
Patients will receive mirogabalin 5 mg once daily for the 12-week duration
Patients will receive a matched placebo for the 12-week duration
Change in Uremic Pruritus Intensity
The mean change in uremic pruritus intensity will be measured by two tools: the Visual Analogue Scale (VAS) and the 5-D itch scale. The VAS ranges from 0 (no pruritus) to 10 (worst possible itching). The 5-D itch scale ranges from 5 to 25, with higher scores reflecting worse pruritus severity.
Time frame: Baseline to Week 12
Percentage of Participants Achieving a Clinically Significant Reduction in Pruritus Severity
Pruritus severity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pruritus) to 10 (worst possible itching). A clinically significant reduction is defined as a shift in severity grade, such as moving from severe/very severe ($\\ge 7$) to mild/moderate (\<7).
Time frame: Baseline and Week 12
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Safety and tolerability will be evaluated and compared between the intermittent and daily mirogabalin arms. This measure will track the number of participants experiencing central nervous system adverse events (e.g., dizziness, somnolence, confusion) and gastrointestinal events (e.g., diarrhea, vomiting), along with the clinical grading of their severity.
Time frame: Up to Week 12
Plan to share: Undecided
Start is estimated for Dec 2026; primary completion for Mar 2027, 3 months later.
Of 52 phase 2 interventional studies under Pruritus, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's planned 3 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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